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July 2016 – Proposed Medicare Appeals Rule & Other Issues

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NATIONAL MEDICARE ADVOCATES ALLIANCE CALL

Monday, July 11th, 2016 – 2:00 P.M., Eastern Time

Call-in Number: 1 (888) 206-2266
Pass Code: 9874704

NOTE: We ask people calling from the same location to gather around one telephone.
This frees up lines and holds down costs.

Please ensure your line is on MUTE for the duration of the call until the QA portion of the Agenda.

_______________________________________________________________________________________________

PROPOSED MEDICARE APPEALS RULE OTHER ISSUES

− AGENDA –

  • Welcome and Housekeeping  (David Lipschutz, Moderator) 
  • News re John A. Hartford Project  (Judy Stein)
  • Proposed Rule to Revise Medicare Administrative Appeals Process (David Lipschutz)
  • Observation Status (Toby Edelman)
    • Advocacy update
    • NOTICE Act and MOON Notice – effective August 2016
  • Medicare Coverage Expansion Updates (Kata Kertesz) 
    • Oral health care
      • Momentum for medically necessary oral health coverage
      • Push for coverage of preventive/routine services
    • Audiology
      • June 23, 2016 press and advocates briefing
  • Proposed Rule: DME Access for Dually Eligible People (Kata Kertesz)  
  • Proposed ESRD Rule
  • Administration on Community Living Grant – For Medicare Beneficiaries Under age 65 (Kathy Holt)
  • Litigation Update   (Ali Bers)
    • Jimmo (Improvement standard)
      • Hearing on Motion for Resolution of Non-Compliance with the Settlement Agreement held May 26, 2016
    • Exley (formerly Lessler) (ALJ Delay Case)
      • Settlement preliminarily approved
    • Barrows (formerly Bagnall) (Observation)
      • Discovery on protected property interest issue; summary judgment briefing
    • Other cases
      • Sherman (Lower level Medicare appeals)
      • Ryan (Prior favorable homebound determination)
      • Lodge (Medically necessary oral health care)
      • Bremby (Per se skilled services)
  • General Medicare QA (Moderator)
  • Wrap-up  (Moderator)
    • Keep informed: Myths and Truths, other information and updates on the Center’s Website
    • Next Call

REMINDER: Other information available at:

July 2016 – Proposed Medicare Appeals Rules & Other Issues

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PROPOSED RULE TO REVISE MEDICARE ADMINISTRATIVE APPEALS PROCESS

As discussed during previous Alliance calls, there is a significant backlog of cases at the third and fourth levels of the Medicare administrative appeals process, the administrative law judge (ALJ) stage administered by the Office of Medicare Hearings and Appeals (OMHA), and the Medicare Appeals Council (Council) administered by the Departmental Appeals Board, respectively.  There have been various proposals to address this backlog, also discussed on previous calls, including those outlined in recent budgets offered by Obama Administration, and a bill introduced by the Senate Finance Committee (see, e.g., our June 2015 Alliance brief at: http://www.medicareadvocacy.org/june-2015-reforming-medicares-appeals-system-other-issues/).   

On June 28, 2016, the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking (published in the Federal Register on July 5th), which, according to an HHS blog post, is part of a “three-pronged strategy to address the backlog:

1)    Invest new resources at all levels of appeal to increase adjudication capacity and implement new strategies to alleviate the current backlog.

2)    Take administrative actions to reduce the number of pending appeals and encourage resolution of cases earlier in the process.

3)    Propose legislative reforms that provide additional funding and new authorities to address the appeals volume.”

As described in the same blog post, through the proposed rule “HHS is proposing additional administrative action to: expand the pool of available OMHA adjudicators; increase decision making consistency among the levels of appeal; and improve efficiency by streamlining the appeals process so less time is spent by adjudicators and parties on repetitive issues and procedural matters. The proposed rule is part of the second prong of our strategy.”

The Center is currently reviewing the proposed rule, and plans to submit extensive comments.  Our overarching, initial concerns with the proposed rule include:

  • Efforts to increase decision making consistency among the levels of appeal
    • As discussed during previous Alliance calls, our experience shows that the high rate of coverage denials upheld at the first two levels of appeal often amount to “rubberstamp” decisions; any reforms that drive the more independent and thorough review at the ALJ level to be more consistent with the lower levels of review – rather than the opposite – could further infringe on beneficiaries’ ability to obtain due process
  • Select Medicare Appeals Council decisions – at the discretion of the Chair of the Departmental Appeals Board – would be designated a “final decision of the Secretary” and considered precedential
    • This could result in restrictions in coverage for needed items and benefits to which Medicare enrollees are entitled by law

The proposed rule is found at 81 Fed Reg 43790 (July 5, 2016): https://www.federalregister.gov/articles/2016/07/05/2016-15192/medicare-program-changes-to-the-medicare-claims-and-entitlement-medicare-advantage-organization.

  • Comments are due August 29, 2016.

OBSERVATION STATUS

            Advocacy Update

The coalition of national organizations supporting the Improving Access to Medicare Coverage Act of 2015 (H.R. 1571/S. 843), which would count all time spent in the hospital towards the 3-day inpatient hospital stay requirement for Medicare coverage of skilled nursing facility care, has grown to 29 members.  See: http://www.medicareadvocacy.org/wp-content/uploads/2016/07/05.09.16-Observation-Stays-Coalition-One-Pager.pdf.

NOTICE Act and the MOON NOTICE – Effective August 2016

As discussed on the last Alliance call, CMS issued proposed rules that announced how CMS intends to implement the Notice of Observation Treatment and Implication for Care Eligibility Act (NOTICE Act).   A final rule has not yet been issued. Effective August 6, 2016, the NOTICE Act requires that hospitals provide written and oral notice, within 36 hours, to patients who are in observation or other outpatient status for more than 24 hours.  The notice must explain the reason that the patient is an outpatient and describe the implications of that status both for cost-sharing in the hospital and for subsequent “eligibility for coverage” in a skilled nursing facility (SNF).

In the proposed rules, CMS announces that it will require hospitals to use a new standardized notice, the Medicare Outpatient Observation Notice (MOON), which it has submitted to the Office of Management and Budget for approval.   As discussed in our April 27 Alert, the Center has significant concerns about the proposed rules relating to the notice required by this Act, including:

  • The proposed rule does not require the hospital to explain in the MOON the specific reason the patient is being considered an outpatient;
  • While all Medicare notices of coverage determinations other than the MOON give beneficiaries an opportunity to appeal to Medicare for a determination of coverage, only the MOON defines the coverage issue as non-appealable;
  • The MOON will not be required for patients whose hospitals choose not to code their “outpatient” Medicare bills as Observation Status; about half of long-stay outpatients are not considered observation status, however, solely because the hospital chose not to bill Medicare for observation hours (the consequences for patients is the same: whether the hospital billed Medicare for observation hours or not, the patient’s post-hospital care in the SNF is not covered because the patient was classified as an outpatient by the hospital). 

The MOON notice (CMS Form Number CMS-10611) can be found here:  

https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing-Items/CMS-10611.html?DLPage=1DLEntries=10DLSort=1DLSortDir=descending

The proposed rules, CMS-1655-P, is at 81 Fed. Reg. 24945 (April 27, 2016), available at https://www.gpo.gov/fdsys/pkg/FR-2016-04-27/pdf/2016-09120.pdf.

The Center’s comments to the proposed rule, filed on June 16, 2016, are available at http://www.medicareadvocacy.org/further-center-comments-on-the-notice-act-june-2016/.

MEDICARE COVERAGE EXPANSION UPDATES

On June 7, 2016, Rep. Jim McDermott (D-WA), Ranking Member of the House Ways Means Health Subcommittee, introduced the Medicare Dental, Vision, and Hearing Benefit Act of 2016 (H.R. 5396).  While the bill is unlikely to move in the near term, it highlights some of Medicare’s major coverage gaps and provides an outline for expanding Medicare coverage to include vision, hearing and dental services and equipment.

Oral Health Care

As discussed during the last Alliance call, the Center for Medicare Advocacy firmly believes that CMS has the legal authority under the Medicare statute to cover medically necessary oral health care – that is, treatment deemed necessary by a physician when a patient’s medical condition is or will likely be complicated by an untreated oral health problem.

As this position gains more momentum among oral health advocates, the Center continues to push for such coverage now, along with working in coalition with others to push for legislation that would provide broader routine, or preventive care, as contemplated by Rep. McDermott’s bill.

Audiology

On June 23, 2016 the Center co-sponsored a press and advocates’ briefing with the National Committee to Preserve Social Security and Medicare (NCPSSM) to discuss the need for audiology coverage in Medicare (see: http://www.medicareadvocacy.org/advocacy-organizations-health-experts-and-elected-officials-call-for-medicare-to-cover-hearing-services/

The briefing highlighted a June 2016 report from the National Academies of Sciences, Engineering, and Medicine titled Hearing Health Care for Adults: Priorities for Improving Access and Affordability which established hearing loss as a significant public health priority. (The report is available here: http://nationalacademies.org/hmd/reports/2016/Hearing-Health-Care-for-Adults.aspx.)   Frank R. Lin, M.D., Ph.D, a co-author of the National Academies’ report, discussed that even mild hearing loss has been shown to double the risk of dementia. Further, hearing loss is directly related to a variety of cognitive impairments, isolation, depression, and increased risk for falls.

The briefing also highlighted Rep. McDermott’s bill, referenced above, (with comments from the Congressman) and the Medicare Hearing Aid Coverage Act of 2015 (H.R. 1653) introduced by Rep. Debbie Dingell (D-MI) (with additional comments from Rep. Rosa DeLauro (D-CT).

PROPOSED RULE: DME ACCESS FOR DUALLY ELIGIBLE PEOPLE

As discussed during the last Alliance call, there is a serious and persistent obstacle to obtaining durable medical equipment (DME) among people with Medicaid and Medicare benefits. While having both types of coverage should enhance benefits, the logistical problems created by the misalignment of Medicare and Medicaid coverage lead to barriers in accessing needed care among vulnerable older adults and people with disabilities.

On June 30, 2016 the Centers for Medicare Medicaid Services (CMS) published a proposed rule primarily focused on End Stage Renal Disease (ESRD) which includes a separate request for information about the difficulties of dually eligible people to obtain Durable Medical Equipment (DME). The request seeks information about the problem, as well as potential solutions.

The Center will respond to the request for information regarding access to DME for dually eligible people. We encourage other beneficiary advocates to do so as well, and to contact us if we can help. CMS seeks specific examples of problems, as well as specific solutions. The Center’s response will include a discussion of:

  • The misalignment of coverage and payment procedures in Medicare and Medicaid that lead to denials and delays of important equipment for this vulnerable population. Generally Medicare provides approval or denial only after delivery of the DME. Without the delivery of the DME to trigger a Medicare coverage decision, suppliers are usually unable to bill Medicaid, because State Medicaid agencies generally require that a bill be submitted first to Medicare. Only after Medicare has rejected the claim or paid its share will Medicaid process a payment. Thus, suppliers do not have assurance that the DME will be covered by Medicare, yet they do not have the ability to bill Medicaid until they have a Medicare decision. This often results in suppliers refusing delivery of DME because they worry they will not be paid by either program.
  • The mismatch between Medicaid and Medicare suppliers, and beneficiary access difficulties; problems with repairs for equipment; delays; and how the competitive bidding process may be affecting availability of suppliers. 
  • The challenges created by the intersection of the two programs. We often hear about problems that begin during the transition from having only Medicaid to also having Medicare coverage.
  • Some promising practices that have worked well to align the two programs. These include a Medicaid prior authorization system in Connecticut that provides suppliers with Medicaid prior authorization – and dually eligible beneficiaries with better access to DME. With assurance that the DME will be covered by Medicaid if Medicare is denied, suppliers are more willing to deliver the necessary DME.

For more information see 81 FR 42801 (June 30, 2016); Request for information (Section IX. Access to Care Issues for DME, page 42864-5.): https://www.federalregister.gov/articles/2016/06/30/2016-15188/medicare-program-end-stage-renal-disease-prospective-payment-system-coverage-and-payment-for-renal

  • Comments are due August 23, 2016.

ADMINISTRATION ON COMMUNITY LIVING GRANT – FOR MEDICARE BENEFICIARIES UNDER AGE 65

An update on the activity generated by Center’s Administration for Community Living grant to expand SHIP/SMP outreach opportunities to Medicare beneficiaries Under Age-65:

The Center has a web-page on the Center’s website (www.MedicareAdvocacy.org) dedicated to issues for people who are under the age of 65 and who are eligible for Medicare benefits. This web-page is available to SHIPs and SMPs and all beneficiaries and advocates of beneficiaries who are looking for information to Medicare beneficiaries who are under age 65. Currently the web-page includes resources and events that will benefit this hard-to-reach population. It also includes information on past webinars and upcoming webinars on topics of particular interest or need for individuals who are under 65 and eligible, or becoming eligible, for Medicare.

Center events and information links for this project are also posted to the SHIP and SMP libraries.

The next webinar will be held on Wednesday, July 27th. Center Executive Director Judy Stein will present on Medicare Home Health Coverage for People with Chronic Conditions (Including a Jimmo update). Please register here.

The webinar entitled “An Overview of Eligibility, Enrollment and Payment” has been translated into Spanish and will be posted to the project web page in the near future. We are also seeking a Vietnamese translation of the presentation.

The Center is developing a new survey with the American Association of People with Disabilities (AAPD) to reach the individuals the project seeks to serve and address their needs. If any organizations would like to participate in this survey process or provide feedback, please contact KHolt@MedicareAdvocacy.org.

Judy Stein and Kathy Holt will be at the National SHIP and SMP conference in August to discuss Under 65 project progress and next steps.

For more information, see: http://www.medicareadvocacy.org/under-65-project/.

LITIGATION UPDATE

  • Barrows v. Burwell (formerly Bagnall v. Sebelius), No. 3:11-cv-1703 (D. Conn.) (Observation Status). In November 2011, the Center for Medicare Advocacy and Justice in Aging filed a class action lawsuit on behalf of individuals who have been denied Medicare Part A coverage of hospital and nursing home stays because their care in the hospital was considered “outpatient observation” rather than an inpatient admission. When hospital patients are placed on observation status, they are labeled “outpatients,” even though they are often on a regular hospital floor for many days, receiving the same care as inpatients.  Because patients must be hospitalized as inpatients for three consecutive days to receive Medicare Part A coverage of post-hospital nursing home care, people on observation status do not have nursing home coverage.  They must either privately pay the high cost of nursing care or forgo that skilled care.  The number of people placed on observation status has greatly increased in recent years.

On September 23, 2013, a federal judge in Connecticut granted the government’s motion to dismiss the lawsuit.  Plaintiffs appealed, but limited the appeal to the issue of the right to an effective notice and review procedure for beneficiaries placed on observation status. 

On January 22, 2015, a three-judge panel of the U.S. Court of Appeals for the Second Circuit decided that Medicare patients who are placed on observation status in hospitals may have an interest, protected by the Constitution, in challenging that classification.  The panel held that the district court erred when it dismissed the plaintiffs’ due process claims, and it sent the case back to that court for further proceedings.  Barrows v. Burwell, 777 F.3d 106 (2d Cir. 2015).

Update: The parties have completed discovery on the question of whether plaintiffs have a “protected property interest” in Part A coverage of their hospital stays, such that they would have due process rights. Plaintiffs received voluminous documentation from the government and conducted depositions of witnesses from the Department of Health and Human Services, Medicare contractors, and some of the hospitals that treated the named plaintiffs. The law firm of Wilson Sonsini Goodrich Rosati, which has helped the Center in previous litigation, is providing pro bono assistance. The government filed its motion for summary judgment and supplemental motion to dismiss on June 16, 2016.  Plaintiffs’ cross motion for summary judgment and opposition to the government’s motions will be filed by July 29, 2016. The briefing is scheduled to be completed by late September.

 

  • Exley v. Burwell (formerly Lessler v. Burwell), No. 3:14-cv-1230 (D. Conn.) (ALJ Delays) The Medicare statute and regulations require that an administrative law judge (ALJ) issue a decision within 90 days the filing of a request for hearing. While the Chief ALJ has stated that individual beneficiary cases should not be delayed, still most of the Center’s cases were exceeding statutory timelines for decisions.

On August 26, 2014, the Center filed a nationwide class action lawsuit in United States District Court in Connecticut. The named plaintiffs, from Connecticut, New York and Ohio, all waited longer than the statutory 90-day limit for a decision on their Medicare appeals. The complaint is available here: http://www.medicareadvocacy.org/wp-content/uploads/2014/08/00083998.pdf.

On January 29, 2015, defendant’s motion to dismiss was denied.  On June 10, 2015, the court granted the plaintiffs’ motion for certification of nationwide class of Medicare beneficiaries who have been or will be waiting more than 90 days for a decision on their timely-filed request for an ALJ hearing.  The parties also conducted discovery.

In March 2016 the court preliminarily approved a settlement.  The proposed settlement addresses delays that Medicare beneficiaries have been experiencing at the ALJ level of review. Among other things, the settlement calls for the Office of Medicare Hearings and Appeals (OMHA) to continue its policy of providing all beneficiary appellants with priority over other appellants in receiving ALJ decisions, to designate a Headquarters Division Director to oversee inquiries about appeals initiated by beneficiary appellants and to address any complaints or questions concerning the processing of those appeals. OMHA will also establish a toll-free help line for beneficiary appellants to be answered by the Division Director’s staff. OMHA will introduce a new, more user-friendly ALJ hearing request form that allows beneficiaries to self-identify, and will also publish data about the length of processing time for beneficiary appeals.

Update: Notice to the class was posted, and then a revised notice after the parties negotiated a small change to the agreement. A fairness hearing is scheduled for August 1, 2016. A link to the class notice is below; we invite you to distribute information about the settlement and fairness hearing to beneficiaries and their advocates.

 

  • Jimmo v. Sebelius, No. 5:11-cv-17 (D. Vt.) (Improvement Standard).  As reported during previous Alliance calls, the settlement in Jimmo was approved on January 24, 2013 during a fairness hearing.  CMS has issued revisions to its Medicare Benefit Policy Manual to clarify that Medicare coverage is available for skilled maintenance services in the home health, nursing home and outpatient settings.  CMS also implemented a nationwide education campaign for all who make Medicare determinations to ensure that beneficiaries with chronic conditions are not denied coverage for critical services because their underlying conditions will not improve. Pursuant to the settlement, counsel for the parties are meeting twice a year to discuss problems with implementation and possible solutions, and are in regular contact between meetings.

On March 1, 2016, the Center and its co-counsel, Vermont Legal Aid, filed a Motion for Resolution of Non-Compliance with the Settlement Agreement.  The filing comes after three years of urging the Centers for Medicare Medicaid Services (CMS) to fulfill its obligation to end continued application of an “Improvement Standard” by Medicare providers, contractors and adjudicators to deny Medicare coverage for skilled maintenance nursing and therapy.

If truly implemented and enforced, the settlement should improve access to skilled maintenance nursing and therapy for thousands of older adults and people with disabilities whose Medicare coverage for skilled care is denied or terminated because their conditions are “chronic,” “not improving,” “plateaued,” or “stable.” Unfortunately, providers and contractors continue to illegally deny Medicare coverage and care based on an “Improvement Standard,” resulting in beneficiaries nationwide failing to obtain needed skilled nursing and therapy coverage. This continued loss of skilled care based on an improvement requirement is occurring despite the assertion by CMS that it has completed the education campaign required by the Settlement. That campaign, however, has clearly failed to educate key components of the provider community and Medicare decision-making system.

Update: The Motion for Resolution of Non-Compliance was fully briefed and oral argument was held on May 26, 2016.  The Center and Vermont Legal Aid were encouraged by Chief Judge Reiss’s understanding of the issues presented and expect a ruling from the court soon.

 

  • Hull v. Sebelius, No. 3:14-cv-801 (D. Conn.) (Lower level Medicare appeals) On June 4, 2014, the Center filed a complaint in United States District Court in Connecticut against Kathleen Sebelius, Secretary of Health and Human Services (at that time), on behalf of plaintiffs who have been denied a meaningful review of their Medicare claims at the first two levels of appeal. The case was brought as a class action on behalf of Connecticut Medicare beneficiaries seeking home health care coverage, and the four named plaintiffs represent the thousands of beneficiaries who cannot get a meaningful review of their cases. Instead, Medicare beneficiaries receive almost automatic denials of coverage, which is essentially “rubber stamped” at both the Redetermination and Reconsideration levels. The problem persists throughout the country.

On December 8, 2014, the court granted the government’s motion to dismiss on the grounds that the named plaintiffs, who are dual eligibles, lack standing because they received coverage of the services at issue from Medicaid.  Plaintiffs filed a motion for reconsideration. On July 6, 2015, the court reconsidered its order but adhered to its decision that the plaintiffs lack standing.  In its reconsideration, the court noted that the Supreme Court granted certiorari in a case that may shed light on the standing issue at dispute. See Spokeo, Inc. v. Robins, 135 S. Ct. 1892 (2015) (granting cert on the following question presented: Whether Congress may confer Article III standing upon a plaintiff who suffers no concrete harm, and who therefore could not otherwise invoke the jurisdiction of a federal court, by authorizing a private right of action based on a bare violation of a federal statute.).

Plaintiffs appealed the case to the Second Circuit on September 17, 2015 (Case No. 15-2949), and at plaintiffs’ request the court agreed to hold the appeal in abeyance pending the outcome of Spokeo at the Supreme Court.

Update: The Spokeo decision was announced by the Supreme Court on May 16, 2016. After analyzing the Court’s rather unclear holding about the injury-in-fact requirements of Article III, plaintiffs concluded that it would not be fruitful to pursue further appeal and the parties stipulated to a withdrawal of the appeal, which was ordered on June 7, 2016.

 

  • Sherman v. Burwell (formerly Olsen-Ecker v. Burwell), No. 3:15-cv-1468 (D. Conn.) (Lower level Medicare appeals) On October 9, 2015, the Center filed a complaint in United States District Court in Connecticut against Sylvia Mathews Burwell, Secretary of Health and Human Services, on behalf of plaintiffs who have been denied a meaningful review of their Medicare claims at the first two levels of appeal. The case was brought as a class action on behalf of Medicare beneficiaries seeking home health care coverage, and the named plaintiff, like the plaintiffs in Hull, represents beneficiaries who cannot get a meaningful review of their cases. However in this “rubber stamp” case, the plaintiff was not eligible for Medicaid and thus was personally financially liable for the Medicare services under appeal.  The plaintiff filed a motion for class certification on October 23, 2015, and the government filed a motion to dismiss on January 13, 2016.

Written discovery was served on the government but the court stayed discovery while the motion to dismiss is still pending. Oral argument was held on the government’s motion to dismiss and the plaintiff’s motion for class certification on February 29, 2016. During the hearing the judge indicated that he was likely to reject the government’s motion to dismiss, however he also found plaintiff’s claim for “commonality” among class members problematic, which may spell difficulty for the class certification motion. The judge took the two motions under advisement and has not yet issued a decision.

The Center is interested in hearing about similar problems that beneficiaries are encountering with respect to “rubber stamp” denials of home health or SNF coverage at the first two levels of appeal.  Advocates and beneficiaries are encouraged to contact Ali Bers at abers@medicareadvocacy.org.

 

  • Ryan v. Burwell, No. 5:14-cv-269 (D. Vt.) (Prior Favorable Homebound Determination) On December 19, 2014, the Center for Medicare Advocacy and Vermont Legal Aid filed a class action lawsuit against Sylvia Mathews Burwell, the Secretary of Health and Human Services, to stop Medicare’s practice of repeatedly denying coverage for home health services for beneficiaries on the basis that they are allegedly not homebound, when Medicare has previously determined them to be homebound. (Ryan v. Burwell). The lawsuit was filed in the United States District Court in Burlington, Vermont on behalf of two Vermont residents, Marcy Ryan and John Herbert, as a regional class action lawsuit covering New England and New York.

On March 25, 2015, the government filed a motion to dismiss on the grounds that plaintiffs lack standing, that the court lacks subject matter jurisdiction, and that plaintiffs have failed to state claim on which relief may be granted.  On July 27, 2015, the court denied the government’s motion to dismiss, finding four separate grounds on which the dually eligible plaintiffs have standing. (Compare Hull, above, in which the court rejected similar standing arguments.) The court also found that it had subject matter jurisdiction and that plaintiffs had stated a claim on which relief could be granted.

Oral argument on the plaintiffs’ motion for certification of a regional class took place in Rutland, Vermont on September 21, 2015.  Judge Crawford requested additional briefing on whether certain beneficiaries should be included in the class, and whether the class should be “closed,” meaning time-limited to the point where the agency removed a Manual provision which is at issue in the case.

On December 2, 2015, the court granted plaintiffs’ motion for class certification and, at request of the plaintiffs, issued clarification on the class definition on February 23, 2016.  The regional class is defined as all beneficiaries of Medicare Part A or B in Connecticut, Maine, Massachusetts, New Hampshire, New York, Rhode Island, and Vermont (Medicare Administrative Contractor Jurisdiction K): (a) who have received a “favorable final appellate decision” that he or she was “confined to the home,” i.e. homebound, in the appeal of a home health nursing or therapy claim denial; (b) who have subsequently been denied, or will be denied, coverage for additional service on the basis of not being homebound, on or after January 1, 2010; (c) who had a non-lapsed, viable appeal of the subsequent denial for coverage of additional home health services as of March 5, 2015, or had a particularized individual basis for tolling of any applicable appeal deadline; and (d) for whom the claim for Medicare home health coverage was filed on or before August 2, 2015.

Written discovery has been served. Defendant’s counsel has approached plaintiffs’ counsel about possible settlement.

 

  • Lodge v. Burwell, No. 3:15-cv-390 (D. Conn., filed 3/17/2015) (Medically necessary oral health care). This appeal filed in federal court, District of Connecticut, presents an opportunity for the court to review whether surgical treatment to a Medicare beneficiary’s teeth damaged by radiation therapy to the head and neck was 1) properly characterized by an Administrative Law Judge as a covered physician service that was medically reasonable and necessary as a part of an overall plan of care for cancer or 2) improperly characterized by the government contractor as excluded dental services.  These competing interpretations depend upon how the specific treatment is characterized. The plaintiff amended the complaint on June 30, 2015 to add a claim under the Administrative Procedure Act (APA), stating that in 1974 the agency removed the word “routine” from the description of excluded dental services without following proper notice-and-comment procedure. Plaintiff requests that the court therefore read the relevant regulation as if the word “routine” had never been removed, which would allow for coverage of his extraordinary, non-routine oral health care.

The government filed a partial motion to dismiss in October 2015. The motion sought to dismiss the APA claim as barred by the statute of limitations. However after the motion was briefed, the government requested and was allowed to withdraw the partial motion to dismiss. The parties also conducted limited written discovery.

Update: Oral argument is scheduled for September 23, 2016.

 

  • Bremby v. Burwell, No. 3:15-cv-1397 (D. Conn.) (per se skilled services). This case was filed on September 22, 2015, in the U.S. District Court for the District of Connecticut.  It challenges the denial of Medicare home health coverage for a beneficiary who required monthly Vitamin B-12 intramuscular injections.  Intramuscular injections are, by regulation, a per se skilled service, and the beneficiary in this case has a condition (Total Gastrectomy) for which Medicare policy expressly recognizes B-12 injections to be a medically necessary treatment.  The Center is interested in hearing about similar problems that others are encountering with respect to denials of home health or SNF coverage for per se skilled services listed at 42 C.F.R. 409.33(b).  Advocates and beneficiaries are encouraged to contact Wey-Wey Kwok at wkwok@medicareadvocacy.org.

Other examples of health care services that are defined by Medicare as skilled in either a Skilled Nursing Facility or for Home Health care include:

(1) Intravenous or intramuscular injections and intravenous feeding.

(2) Enteral feeding that comprises at least 26 per cent of daily calorie requirements and provides at least 501 milliliters of fluid per day.

(3) Nasopharyngeal and tracheostomy aspiration;

(4) Insertion and sterile irrigation and replacement of suprapubic catheters;

(5) Application of dressings involving prescription medications and aseptic techniques;

(6) Treatment of extensive decubitus ulcers or other widespread skin disorder;

(7) Heat treatments which have been specifically ordered by a physician as part of active treatment and which require observation by nurses to adequately evaluate the patient’s progress;

(8) Initial phases of a regimen involving administration of medical gases;

(9) Rehabilitation nursing procedures, including the related teaching and adaptive aspects of nursing, that are part of active treatment, e.g., the institution and supervision of bowel and bladder training programs.

On December 28, 2015, the government filed a motion to remand the case to the Medicare Appeals Council. On April 29, 2016, the court granted the government’s motion to remand, but retained jurisdiction and ordered defendant to submit a status report on further action taken by the Secretary of Health and Human Services by August 15, 2016.

Update: On June 13, 2016, the Medicare Appeals Council issue a new decision, favorable to the beneficiary. It decided that the monthly Vitamin B-12 injections should be covered, however its rationale was questionable.  The Appeals Council stated that the medical records did not “clearly indicate the purpose for giving” the B-12 injections, “nor do most of the skilled nursing visit notes specifically reference the beneficiary’s gastrectomy.”  It found coverage as warranted nonetheless because the beneficiary’s plans of care referenced the total gastrectomy.  The decision made no reference to the serious problems with the original Appeals Council decision, which theorized that the beneficiary could have performed the intra-muscular injections herself. Despite the favorable ruling, the Center is not satisfied with the reasoning of the Appeals Council and expects to alert the court of its objections. The Center also awaits the status report from the government, due to be filed by August 15, 2016.

Selected Beneficiary Comments from Center for Medicare Advocacy Petition Regarding Oral Health Care

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“Dental care has been the most frustrating part of being a senior, and has the most to do with maintaining health in general.” – Michael Allen, California

“This is a very important issue, the ability to eat is vital to a person[‘s] health, at age 71 I needed new dentures and I had no coverage, they cost $4500.00 where is someone on Social Security supposed to get this kind of money? … These… need to be covered by Medicare.  Living on Social Security does not leave any extra money to cover these expenses and they are a vital part of health.” – Janie Anderson, CA

“Dental care is very important and often too expensive for seniors … Dental care is very important and not affordable for many.”  – Dorothy Anderson, MA

“Infections in the mouth will travel to other parts of the body.” – Ellen Asbell, PA

“Many of my health problems are made worse due to my inability to afford dental care.” – Ellene Ashe, CA

“Without good oral health care you can become very ill; it would be a blessing for me to have coverage.” – Janet Atkins, FL

“I was without dental insurance for 15 years. I almost lost all my teeth before CHAMPVA added dental. People who are older need more dental care, care that affects their overall health.” – Kathryn Bakston, GA

“My girlfriend had a terrible infection in her spine and it came from a bad tooth! She was in the hospital a week and then nursing rehab a month. If dental was included in Medicare, this might have been avoided.”  – Bruce Bauer, OR

“I am a senior who has lost four teeth so far because I can’t afford the dental care necessary to save them. This is not due to poor dental hygiene. It is due to medical issues including dry mouth, which causes decay. I have cleaning and fillings done at a low-income clinic but even their fee for anything else is too high … I and many other seniors who worked hard and paid taxes will continue losing teeth with no other option since even dentures aren’t covered. This affects our general health negatively. Please do something about this.” – Cheryl Biale, WA

“I had an infection at the end of a root canal that required endodontic surgery. Although this was an infection, and failure to treat it could result in sepsis and/or brain inflammation, the surgery was considered a dental issue because of the location of the infection (in the cavity left by a prior root canal procedure) and I was billed over $2000, none of which was covered by medicare. It took me two years to pay for this. Failure to treat dental issues results in a threat to health. Why are they exempted from senior health care?” – Judith Blair, NY

“I know someone who needs tooth extractions due to radiology to treat tongue cancer. He has Medicare only, so he lacks coverage to have the affected teeth extracted. Instead, the teeth are steadily falling out and he is inhaling them into his lungs.” – Jessica Bronson, DC

“I am a senior citizen, and cannot meet my monthly expenses as it is. Now I am told that my teeth are in seriously bad shape. I have to eat so I need food, but I also need to get my teeth fixed to eat. It makes no sense why Medicare does not cover medically critical oral health! Please help us!!! I am having a root canal tomorrow. Had I been able to afford preventative health care of my mouth, this would not have been necessary. I will have to go to an oral surgeon if the Endodontic specialist cannot successfully do the procedure due to calcification, etc. I have already had 3 teeth pulled. There is nothing in their place because I cannot afford to do anything to replace them!! There are so many people like me!! Medically necessary oral health care is critical and will save money in the long run.” – Beverly Burgos, VA

“My husband and I, both disabled, are unable to afford dental care on our monthly income. That means he has more sinus infections, and they are more severe. The same goes with earaches. I can attribute many of my headaches to TMJ, but without coverage, I can’t get treatment.” – Amy Burdette, KS

“I am a public Health Dental hygienist as well as a Medicare beneficiary. It is appalling that Medicare forgets that oral health is as important as general health! I see so many patients who are on Medicare and who need fillings, extractions, surgeries etc. but are on limited income and may have Medicaid which does not cover many dental services and the patient suffers and goes to ED where they only get meds to help with the pain! A waste of tax dollars when we could these wasted dollars to help our seniors to keep their mouth healthy and pain free. Oral health also impacts diabetes control, cardiovascular health, etc.” – Susan Camardese, MD

“I have broken teeth and crowns, and I cannot get them repaired because I cannot afford dental care. This is a serious problem as the sites could easily become infected and eating is difficult. It is absurd that Medicare will not cover oral health care. Teeth impact the entire body.” – Susan Dean, CO

“I am 65 and have been on Medicare disability due to TBI in 2001. I now have Sjogren’s disease and am losing teeth due to oral problems caused by this disease. Frequent infections in roots of my teeth are causing/contributing to systemic conditions because I cannot get dental care – it is being denied as ‘not medically necessary’ by Medicare. My SSD income is barely sufficient to cover my living expenses and medical copays. I cannot afford private dental insurance or pay for dental care myself.” – Judith DuBose, TN

“As it turns out I have had dental issues for many years. Extractions began because of chemotherapy and an immune disorder that causes very high calcium which deposited at the base of my lower teeth. Over the years all but two were removed and I wore a bridge. However, because of these problems I had a very hard time eating and lost 45 pounds in 2 years. It became clear that only implants and a bridge would work for me. So I needed to dip into my very limited savings to pay for the work. I was severely malnourished and am still trying to get my digestive system working normally again. I am 74 and have only social security and a small $92.00 monthly annuity. It is a struggle to pay for prescriptions, health insurance, utilities, rent, vision care, etc. I see so many seniors missing teeth. I believe that Oral health is health care and should be included in Medicare.” – Shirley Deininger, AZ

“If you have no teeth it is hard to eat! It is hard to eat a healthy diet when you have no teeth!” – Mercy Drake, AZ

“This is very true, really doesn’t make sense that Dental care is not considered health care…..I know, having broken a tooth, and fearing to got to dentist, thinking could not afford as a retiree. I did, but luckily it was during summer months when could afford not having to heat my home in the Northeast area of the country.” – Gail Fiske, VT

“I haven’t been to a dentist in seven years. I’m permanently disabled and on SSD and Medicare. I just can’t understand why I have no dental coverage under Medicare?! I was going to get to a dentist but then my medication copays, I’m on a plan from the state of NJ for low income folks, jumped by $350 this year!!!!!! So no dentist in my near future and my teeth are really starting to hurt, I think something is wrong…….. oh well.” – Matthew Franck, NJ

“I had to fight to get my Mom coverage when her mouth was infected-red, swollen and she had a fever. Medicare should cover all except cosmetic dental, but even cavities and gum problems lead to health problems overall So when they get bad enough it is no longer cosmetic, but a question of health.. Poor dental care contributes to heart disease and could lead to sepsis. You cannot separate one part of the body from the other. If dental care wasn’t important, why would dentists need to be doctors?” – Jane Freidel, PA

“I’m a senior citizen receiving S.S. less than what’s considered average. When the $ gets to me medicare has been deducted with the remainder I pay my medicare supplements and monthly expenses. It’s been years since I bought cloths only a couple of pairs of shoes that are comfortable to wear because of gouty arthritis. I can’t afford dental ins that will pay for several crowns that have worn out. So far those teeth missing their crowns haven’t required surgery. If medicare provided seniors help with expenses involved with the more expensive dental work then oral surgery could be avoided.” – J. Gerulski, TX

“I have learned the hard way just how important oral health care is! In 2008, I had a heart attack and was diagnosed with type 2 diabetes, which by-the-way, was the cause of my heart attack! I was told then that I must visit my dentist at least every three months for dental care because the not-so-good teeth in my mouth at that time, were most likely contributing to my heart attack! So, I had two strikes against my health, hooray for me!! Oral Health Care is Health Care!” – Barbara Gibson, PA

“Because I am auto-immune non-specific, I had to have all my teeth pulled in 2006 or 2007 .. This IS NOT DENTAL, this MEDICAL!!! I also am totally disables and have been since 2003 and I am no3 62-1/2 yrs. old. I pay for all my own Medicase and my BC/BS premiums on the pennies I receive from working all my life and this is what I receive??? Where is the Justice and fairness is this?” – Cluadia Goggin, IL

“To carve out the mouth for exclusion is either ignorant or callous. The health of the mouth and the teeth and the roots of the teeth and the tissues of the mouth are all integral to the health of a person. The roots in the mouth actually correspond to the organs and systems in the body. Seniors, especially, are vulnerable to diseases and decay. Please help our seniors gain access to affordable dental and mouth care.” – Jo Greenwald, HI

“Two good friends of ours passed away recently because an infected tooth was not treated and the infection spread throughout their whole body and they died from complications caused by it. Mouth infections can cause endocarditis which my husband almost died of. Oral health needs to be taken care of immediately and should be an integral part of any health care plan. People have no idea how dangerous a mouth infection can be.” – Catherine Mitchell, NC

Center Comments on Proposed Changes to Physican Payments

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June 27, 2016

Centers for Medicare Medicaid Services
Department of Health Human Services
Attention: CMS–5571–P
P.O. Box 8013

Baltimore, MD 21244–8013

Submitted electronically to: www.regulations.gov            

Re:  CMS–5517–P

To Whom It May Concern:

The Center for Medicare Advocacy (the Center) is pleased to provide the Centers for Medicare Medicaid Services (CMS) comments on the proposed rule on the Medicare Program Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule (CMS–5571–P).

The Center, founded in 1986, is a national, non-partisan law organization that works to ensure fair access to Medicare and to quality health care. We draw upon our direct experience with thousands of individuals to educate policy makers about how decisions affect the lives of real people. Additionally, we provide legal representation to ensure that people receive the Medicare coverage for which they qualify, and the quality health care they need.

Overall, we appreciate that the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) moves the Medicare program away from the flawed Sustainable Growth Rate (SGR) physician payment formula, and provides an opportunity to change provider incentives through payment mechanisms.  Although we generally support the proposed rule’s MIPS and APM Incentive, we have some reservations regarding key aspects of the proposed rule. These concerns are addressed in the comments below.

I. Overarching Comments

While our comments below are separated between those applicable to Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APM), we offer the following overarching comments applicable to both topics.

A. Appropriate Outcome Measures

The Center echoes some of the comments to this proposed rule offered by the Medicare Payment Advisory Commission (MedPAC) in their June 2016 report to Congress. Specifically, incentive payments to physicians under MACRA’s new reimbursement system should be linked to the actual quality of care provided.[1] Throughout our comments, we discuss how outcome measures might be better incorporated into this new system. 

A focus on outcome measures, however, should not result in incentives to provide care only to individuals whose condition is expected to improve. Despite the Settlement in the Jimmo v. Sebelius case, which states that therapy and skilled nursing services are appropriate for Medicare beneficiaries in order to maintain an individual’s condition or slow deterioration, the Center continues to hear from beneficiaries who are denied such services because their conditions do not improve.[2]  Sometimes an individual’s condition cannot and will not improve; yet skilled nursing and/or therapy are necessary to maintain the individual’s vulnerable condition. Thus, any outcome measures implemented under MACRA must be based on meeting progress toward individually assessed needs, not improvements in the patient’s condition.

B. Socioeconomic Status

The Center applauds CMS for examining the HHS’ Office of the Assistant Secretary for Planning and Evaluation (ASPE) study regarding the issue of risk adjustment for socioeconomic status in quality measures, as required by the IMPACT Act, prior to making any changes to quality measures.

We reiterate our on-going concerns regarding risk adjustment for quality reporting and pay-for-performance programs based on socioeconomic/sociodemographic status (SES/SDS). We believe that adjusting for SES factors could lead to several harmful unintended consequences for disadvantaged patients.  First, risk adjustment has the potential to mask existing disparities in care that low income patients receive, rather than expose and address these disparities.  Attempting to adjust for, and over-simplify, the complexity of chronic conditions only perpetuates the inequities.

Also, risk adjustment could create two divergent standards of care for healthcare units based on the wealth or poverty of the populations they serve.  Adjusting scores for healthcare units with significant proportions of disadvantaged patient populations would in effect lower the bar for healthcare units that treat these populations.  This type of adjustment would allow distinct and unequal quality standards for poor patients and wealthy patients. Also, the root of the disparities in care is not likely to be addressed if the differences are concealed through the automatic and inaccurate inflation of performance scores. 

We acknowledge that disparities exist between the quality of care delivered to low income populations and that delivered to higher income populations.  We also recognize that there are social and economic reasons that require alternative interventions or approaches by healthcare units in order to limit disparities in care for different populations.  It is critical to identify those factors, and develop systems to address and seek to overcome the obstacles to high quality care for these populations.  Addressing the root causes is foundational in developing and employing changes that target these causes in order to improve care equitably. 

We therefore welcome the results of the ASPE study, and look forward to future CMS proposals. We are confident that the proposals CMS will develop based on this ASPE data collection will be aimed at supporting high need patients by addressing health disparities. We therefore applaud CMS for the commitment to ground any possible future changes to the quality system in the data collected by the ASPE study.

We support CMS’ measured approach to incorporating socioeconomic status into quality measures. We look forward to reviewing any future measures and having the opportunity to comment on those measures when proposed.

II. Merit-Based Incentive Program System (MIPS)

A. Background

The Merit-Based Incentive Program System (MIPS) is the consolidation of

three existing Medicare programs: (1) the Physician Quality Reporting System, (2) the Value-Based Payment Modifier, and (3) the Medicare Electronic Health Record (EHR) Incentive Program.[3] In combining these three pre-existing programs under the MIPS umbrella, CMS is proposing to score eligible physicians,[4] for the purposes of payment, through the use of four weighted performance categories: (1) Quality, (2) Resource Use, (3) Clinical Practice Improvement Activities, and (4) Meaningful Use of Certified EHR Technology.[5] Based on the composite performance score of these four categories, eligible physicians will be subject to a payment increase or decrease of four % in 2019, five % in 2020, seven % in 2021, and nine % in 2022.[6]

Through this framework, CMS envisions that MIPS will incentivize physicians to “engage in improvement measures and activities that have a proven impact on patient health and safety and are relevant to their patient population.”[7]  As discussed below, however, the Center is concerned that actual improvements in performance might be jeopardized by the proposal to offer physicians too much latitude in their selection of how they will be measured.

B. Quality Category

The Quality section of the proposed rule would afford physicians “the flexibility to determine the most meaningful measures and reporting mechanisms for their practice.”[8] As a result, physicians will be given the authority to self-select just six measures out of all potential MIPS measures in a given year.  In comparison to the current model, the Physician Quality Reporting System already requires physicians to report on at least nine measures.[9] By allowing physicians to self-select so few measures, certain critical measures could be ignored while clinicians emphasize their self-determined strengths. CMS risks rewarding physicians for spotlighting only the positive qualitative aspects of their practices to the detriment of the Medicare program and its beneficiaries.[10] As CMS acknowledges in the proposed rule, physicians could game the system by “report[ing] only on measures for which they have a sufficient sample size.”[11]

Although we acknowledge that not all physician practices are alike and that physicians need a modicum of flexibility in reporting to CMS, we strongly urge CMS to maintain greater control of the reporting under MIPS and to provide more thoroughly defined measurements. Further, we strongly urge CMS to incorporate more reporting requirements that would assess the actual and overall quality of care being provided to beneficiaries.

C. Resource Use Category

While the Center recognizes there may be value in measuring the costs per episode of care or per particular conditions under the MIPS program, any analysis of costs must be coupled with an analysis of patient outcomes and patient needs prior to any determination of what constitutes appropriate funding. Such a holistic weighing of considerations could serve to offset clinician incentives to lower costs at the detriment of patient needs.

The Center welcomes CMS’s recognition that some clinicians have a larger concentration of disadvantaged patients and that resource use measures—derived from administrative claims data—should be adjusted accordingly. Additionally, CMS lists the right kind of risk factors that should be taken into account: a combination of chronic conditions, current health status, recent care utilization, geography, ethnicity, health status, and certain demographic and socio-economic characteristics. [12] We request, however, clarification on the definitions CMS uses for “socioeconomic and demographic characteristics,” as they are currently undefined.[13] Furthermore, we welcome that MIPS clinicians and their patient pool will be measured relative to their peers.[14] Nevertheless, given that four of the measures applied to administrative claims data measure coronary diseases and diabetes—ailments that especially affect less advantaged groups—it is particularly important that well-designed risk adjustment methods be in place that do not penalize or dis-incentivize clinicians from treating disadvantaged groups.  As previously outlined, we support CMS in examining the ASPE study regarding the issue of risk adjustment for socioeconomic status in quality measures, as required by the IMPACT Act, prior to making any changes to quality measures.[15]

D. Clinical Practice Improvement Activities Category

Clinical Practice Improvement Activities (CPIA) have the potential to promote care coordination, meet the health and safety needs of patients, and create greater communication between providers and patients. The CPIA category should lead to sustained transformation and improvement of clinical practice over time. The Center recognizes the potential this category has in future years to improve the quality of care that patients receive. In order for this to come to fruition, the great potential of the CPIA category should be tweaked in future years to better guarantee that the category’s goals can be realistically met.

i. CPIA Measures

The Center seeks clarification from CMS on how clinicians can meet specific measures. The proposed rule should provide specificity to adequately guide clinicians to properly complete the measures and meet goals established by the CPIA category. The following clinician measure demonstrates the current lack of specificity: “Participation in research that identifies interventions, tools or processes that can improve a targeted patient population.”[16] Additionally, what is to stop a clinician from not understanding the following measure and interpreting as he or she sees fit: “Engage patients and families to guide improvement in the system of care”?[17] The Center welcomes the attention CPIA places on health disparities, but the measures relating to this subject are so vague that they could be better served by more specificity. One measure reads as follows: “Take steps to improve healthcare disparities, such as Population Healthcare Toolkit or other resources identified by CMS…Refer to the local Quality Improvement Organization (QIO) for additional steps to take for improving health status of communities.”[18]

In order for clinicians to better understand and reduce health disparities, there should be measures that specifically incentivize the reporting of data that is disaggregated by race/ethnicity, sexual orientation, and gender identity. As in other places throughout the list of CPIA measures, specific examples of clinician mitigation of health disparities would better guarantee that the goal of this measure is achievable.

Another impediment towards the kind of meaningful transformation of patient health that CPIA sets out are the points that clinicians can receive for these many process measures. While a clinician can receive points for conducting a mental health screening, he or she is not judged on how well he or she completes a measure.[19] One solution to this problem might be for measures to be more outcome based and less process based. CMS could also better guarantee how well a clinician performs on a measure by conducting audits that monitor clinician practices.

The lack of effective measures and minimal participation providers may use to satisfy CPIA measures also acts as a barrier to achievement of the program’s goals. Some high-level activities receive 30 points of the required 60 CPIA points and medium activities are worth 20 points. It is possible to do two 30-point activities and meet the CPIA requirement. Moreover, activities only have to be performed for at least 90 days out of 365.[20] Conducting mental health evaluations for only three months of the year, for instance, would not likely meet the needs of patients who get their yearly checkup during the other nine months of the year the clinician chooses not to satisfy CPIA’s measures. With this limitation in mind, the Center recommends that CMS extend this requirement.

The Center appreciates that CMS is open to recommendations every year for possible new measures and new language designed to help clinicians and CMS meaningfully transform patient care.[21] As written, however, clinicians can marginally complete the Clinical Practice Improvement Activity category’s measures. The Center hopes that in future years CMS will continuously improve the CPIA category to be more meaningful, more evidence-based, and better positioned to promote better patient health outcomes.

E. Advancing Care Information Category

The Center strongly supports measures within the Advancing Care Information portion of MIPS that lead to greater openness and communication between providers and patients, patient engagement in their health care, care coordination, and interoperability.

i. Measures

The measures that providers may complete to be in compliance are not sufficient enough, however, to meaningfully achieve the above-cited goals. In future years, the Center recommends more stringent measures and scoring in order to better ensure that there is a meaningful transformation that leads to better outcomes for patients.

One of the primary impediments to such interoperability and outcomes is the so called “one-patient” threshold for satisfying many of the measures within ACI. This low threshold, and the ease at which clinicians may complete ACI requirements, does not encourage substantial advances for Medicare patients. A clinician can score, for instance, both base score and performance score points by electronically transmitting one prescription a year—doing this gives a clinician 1/5th of their required ACI score.[22] The Center recognizes that it may be important for providers who never had to previously participate in the Meaningful Use program to catch up to those providers who already have experience with Electronic Health Records and the measures associated with them. We therefore encourage CMS to make the ACI measures more difficult, more meaningful, and more likely to improve patient health outcomes after FY 2017. If FY 2017 is a time for newly-participating physician assistants and nurse practitioners to acquire and learn EHR technology, all participating clinicians might be able to satisfy more meaningful measures in future years.

In successive years, measures should not merely be process measures such as those that award 10 points (10% of the ACI score) if a patient “views, downloads, or transmits information.”[23] This example can become a meaningful outcome measure if it instead measured patient needs met as a result of patients viewing and downloading information concerning, for instance, at-home physical therapy exercises a clinician has recommended. CMS could also, for example, measure outcomes resulting from patient-clinician information exchanges to complete prescription medication changes.

Another way to better meet patient needs in future years is to adjust the clinician’s possible base score. After FY 2017, it will no longer be necessary to allow a base score—created as a way for newly-participating clinicians to learn EHR technology and satisfy some basic ACI requirements—to make up 50 % of the total ACI score because clinicians will have become more familiar with certified electronic health record technology during FY 2017. Furthermore, in FY 2017 physicians who previously participated in the meaningful use program and have an existing familiarity with EHR and CERHT can easily satisfy ACI requirements; the kinds of measures they can satisfy in FY 2017 are partly less stringent than the measures satisfied under the Meaningful Use program. In future years, the Center recommends lowering the total number of possible base measure points designated for EHR technology and basic ACI requirements so that clinicians will satisfy more meaningful performance score measures.

ii. “Meaningful User” Threshold

The Secretary can at any time certify that 75% of participating clinicians become “meaningful users” of Certified Electronic Health Records Technology and can then lower the weight of the ACI category from 25% of the total MIPS score to 15%. The definition of what a “meaningful user” is undefined in the proposed regulation.[24] The Center recommends that “meaningful user” be specifically defined, to better achieve substantive improvements in interoperability and better patient health outcomes in the ACI subset of MIPS. Given the low bar with which clinicians may complete certain ACI measures, even if 75% of all participating MIPS clinicians achieve a 100% score on ACI in FY 2017, patient health outcomes would not likely change that much as a result.

The Center recommends that, following the development of more meaningful ACI measures in future years, CMS define a meaningful use threshold as one in which at least 90% of participating clinicians receive 100% of their ACI points. It is important to clearly define expectations and set a higher standard in order to achieve interoperability and EHR-aided, improved health outcomes for Medicare beneficiaries. For similar reasons, the Center also opposes any move to lower the meaningful use threshold below the current 75% amount.

iii. Attempts to Prevent Information Blocking

The Center supports CMS’s proposed requirement that clinicians certify they have not prevented interoperability and they have shared patient information with other clinicians.[25] The Center requests this self-reported measure be validated by audits of clinician EHR systems in order to certify whether clinicians engage in information blocking.

III. Alternative Payment Models (APMs)

A. Assessments in Advanced APMs

The proposed rule provides that Advanced APMs must do the following: (1) require participants to use certified EHR technology, (2) require APMs to base payments on “quality measures comparable to those in the quality performance category of MIPS,” and (3) require APM entities to “bear more than a nominal amount of risk for monetary losses.”[26] By adhering to these Advanced APM participation requirements, Qualified Participants (QPs) could receive in FY 2017 a lump sum bonus of five % of the estimated aggregate payments from the Medicare Part B services they provided in the preceding year.[27] Nevertheless, the proposed rule provides few requirements that ensure that APM incentives are truly rewarding physicians for delivering quality care.

The Center is concerned about how meaningful an Advanced APM assessment will actually be when the proposed rule emphasizes that “[w]hether an APM is an Advanced APM depends solely upon how the APM is designed, rather than on assessments of participant performance within the APM.”[28] The proposed rule attempts to reconcile the assessment gap between an Advanced APM and the participant’s actual performance by arguing that “[p]erformance assessments are already part of APMs, and [CMS] believe[s] it is important and consistent with the statutory framework to continue to foster flexibility in structuring the specific rewards and consequences of performance within each APM.”[29]

Unfortunately, it is unclear how the design of an Advanced APM necessarily equates to proper performance assessments, especially when flexibility is a factor. For instance, the proposed rule highlights that “an APM that ties payments to performance on quality measures comparable to those under MIPS may be an Advanced APM regardless of an Advanced APM Entity’s actual performance on those quality measures.”[30] However, as illustrated above, quality measures such as those under MIPS already provide physicians the opportunity to self-select only the qualities that they want to have measured.[31] We do not believe that multiple layers of self-selected quality measures assist in incentivizing physicians to improve the delivery of care. Given the increased rewards inherent in the Advanced APM model over time, we strongly urge CMS to undertake additional, more meaningful, performance assessments.

B. Outcome Measures

The proposed rule argues that outcome measures are “a priority measure type”

and that CMS wants to encourage that outcome measures be factored in when quality performance assessments are being completed.[32] In this aim, the proposed rule states that an “Advanced APM must include at least one outcome measure if an appropriate measure . . . is available on the MIPS list . . . at the time when the APM is first established.”[33] Unfortunately, the proposed rule continues by adding that, if no outcome measures were actually on the MIPS list at the moment the APM was established, “CMS would not require an outcome measure be included after APM implementation.”[34] Again, the proposed rule’s limited timing and subsequent failure to require any meaningful outcome measure might undermine CMS’ stated objectives. Ensuring that well-defined outcome measures are necessarily included in performance assessments will ensure that beneficiaries are receiving better care. Medicare value-based payments must ensure that physicians have an incentive to secure better health outcomes.

C. Clinical Care Model

The Center urges CMS to require that Advanced APMs use a clinical care model that results in improved delivery of care and reinforces a strong foundation of primary care (for example, greater care coordination and communication; use of shared care planning and partnership with patients at all levels of care; timely access to care; and demonstration of improved patient care experience).

With the exception of models considered to be Medical Home Models, there are no requirements for the Advanced APM program addressing the clinical care delivered by the underlying APM.  Meaningful transformation to value based payment requires that the transition to APMs also result in improved delivery of care.

We strongly recommend that as entities take on financial accountability for quality performance and value, assume financial risk, and move towards capitation-like payment models, these entities must likewise be able to demonstrate they promote and support a sustainable, patient-centered model that is accessible, effective, and evidence-based.

We therefore recommend that CMS add an additional criterion for Advanced APMs that requires them to demonstrate their payment approach will reinforce the delivery of coordinated patient-and family-centered care with a strong primary care foundation.

We strongly encourage CMS to consider requiring all models qualifying as Advanced APMs meet care delivery requirements similar to those for Advanced APM Medical Home Models.  Further, we urge CMS to require Medical Home Models seeking to qualify as an Advanced APM to meet all seven requirements laid out in the rule’s definition of a Medical Home Model.

The special consideration given to Medical Home Models as Advanced APMs acknowledges the critically important role of primary care. We strongly support the separate financial standards for Medical Home Models and appreciate CMS’s attention to place a high-value on the provision of primary care.

However, with regards to the requirements around Medical Home Models, we urge CMS to go further and require Medical Home Models seeking to qualify as Advanced APM to meet all seven of the domains listed in the proposed rule’s definition of a Medical Home Model: (1) planned coordination of chronic and preventive care; (2) patient access and continuity of care; (3) risk-stratified care management; (4) coordination of care across the medical neighborhood; (5) patient and caregiver engagement; (6) shared decision making; and (7) payment arrangements in addition to, or substituting for, fee-for-service. All seven domains are key elements of a true Medical Home Model. Particularly with respect to first six criteria, we can identify no criterion that could acceptably be missing from a high-quality medical home.

The requirements for Medical Home Models also need much greater definition and specificity, particularly with respect to patient and caregiver engagement and to shared decision-making.

D. Transparency, Consumer Protections, and Stakeholder Engagement in Advanced APMs

Encouraging transparency, the proposed rule states that CMS will develop a method to identify and notify the public of specific APMs that CMS considers are Advanced APMs.[35] The proposed rule clarifies that “making this information available in an accessible format is important for stakeholders to understand how CMS applies the Advanced APM criteria to existing APMs, and to be informed as early as possible about whether an APM they are considering joining is an Advanced APM.”[36] We agree; however, we believe accessibility alone is not sufficient to ensure that the voices of beneficiaries are heard. Although the process may be transparent after the fact, we strongly encourage CMS to develop additional processes to allow stakeholder engagement during the period of determination. Patients, advocates, and physicians should be included in the entire process as co-creators, and not only informed at the end of the process.

The Center urges CMS to thoughtfully develop and properly measure enhanced consumer protections as more clinicians move into Advanced APMs.  Greater transparency in Advanced APM measurements would provide helpful information for patient advocates to assist CMS, improve future Advanced APMs, and help ensure they are not encouraged to select only the healthiest patients.

New models should better protect disadvantaged and at-risk patient populations from the get-go. When new Advanced APMs are considered, CMS should provide their quality and resource-use data to the public for comment. Further, given the complexity of certain Advanced APMs, we encourage CMS to require them to provide linguistically and culturally appropriate materials for patients. We ask CMS to provide prototypes of these materials to patient advocates to review before they are finalized.

Conclusion

The Center for Medicare Advocacy greatly appreciates the opportunity to provide comments on the proposed rule on the Medicare Program Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule.

For additional information, please contact our Senior Policy Attorney, David Lipschutz at 202-293-5760 or Dlipschutz@MedicareAdvocacy.org.  Thank you.

Sincerely,

Judith Stein
Executive Director/Attorney

Kathleen Holt

David Lipschutz

Kata Kertesz

Matthew Hubbard

Dara Valanejad


[1] MedPac. “Medicare and the Healthcare Delivery System.” June 2016. http://medpac.gov/documents/reports/june-2016-report-to-the-congress-medicare-and-the-health-care-delivery-system.pdf (site visited June 22, 2016). P. 49.
[2] Center for Medicare Advocacy. “Why the Jimmo v. Sebelius Case Matters: Improvement Standard Stories.” http://www.medicareadvocacy.org/why-the-jimmo-v-sebelius-case-matters-improvement-standard-stories/ (site visited June 22, 2016).
[3] Id. at 28162.
[4] See id. at 28163 (“MIPS eligible clinicians will include physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and groups that include such clinicians.”).
[5] Id. at 28247
[6] Id. at 28247.
[7] 81 Fed. Reg. at 28185.
[8] Id.
[9] See id. at 28187 (arguing that the reduction “decreases the MIPS eligible clinician’s reporting burden while focusing on more meaningful types of measures”).
[10] Although CMS notes that it plans to increase reporting requirements over the next few years through notice and comment rulemaking, the requirements currently proposed will have a negative impact on beneficiaries in the meantime by not making physicians accountable for the total quality of the care they provide. Id.at 28187.
[11] Id.
[12] Id. at 28196-7.
[13] Id. at 28197.
[14] Id.
[15] Id. at 28196.
[16] Id. at 28573.
[17] Id. at 28580.
[18] Id. at 28573.
[19] Id. at 28585.
[20] Id. at 28211.
[21] Id. at 28215.
[22] CMS. “Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models.” Proposed Rule. https://www.federalregister.gov/articles/2016/05/09/2016-10032/medicare-program-merit-based-incentive-payment-system-mips-and-alternative-payment-model-apm (site visited May 23, 2016). P. 28228.
[23] Id.
[24] Id. at 28226.
[25] Id. at 28386.
[26] Id. at 28165.
[27] Id. at 28294.
[28] Id. at 28298.
[29] Id. at 28299.
[30] Id.
[31] See supra notes 12-7 and accompanying text.
[32] 81 Fed. Reg. at 28302.
[33] Id.
[34] Id.
[35] Id. at 28298.
[36] Id.

ALS-MAP: Webinar 1 Q&A

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Medicare Access Project for People Living With ALS

Medicare Overview – With an Emphasis on the Home Health Care Benefit

Frequently Asked Questions and Answers


  • General Home Health Questions
  • “Homebound” Questions
  • Specific Coverage Questions

  1. Can they be using a walker instead of crutches in homebound example?
    Yes, the homebound definition generally is intended to provide home health care for people who lack an ordinary ability to leave home. The definition includes a provision that an individual requires assistance of an individual or supportive device and it requires “considerable and taxing effort” to leave home.
  2. Are home health aides able to care for someone with a tracheostomy?
    Yes, but typically not care that requires “skilled” care. Home health aides provide primarily personal, hands-on care. A home health aide may assist with tasks such as dressing, bathing, assisting someone to transfer or reposition, laundering of personal items or bed linens, and similar tasks.
  3. When a nurse comes, we were told that they have to have a list of tasks that will keep them there for that amount of time, is that true?
    Once skilled nursing care is determined as reasonable and necessary, the amount of time that a nurse is required to be in the home should be delineated in the plan of care and should be adequate time to cover the skilled tasks that the nurse is to perform (observation, assessment, care plan management, patient education services, other specific services.
  4. Can you give us an example of needs which would require 28-35 hrs/wk of care?
    The 28-35 hours per week would include a combination of what Medicare defines as both skilled nursing care and home health aide services (also called personal care services). Generally, skilled nursing care includes overall management and evaluation of care plan, observation and assessment of the patient’s changing condition, patient education services, and other skilled nursing tasks. Generally, personal care services  include assistance in dressing, eating (not tube feeding, which is considered a skilled task), toileting, bathing, positioning, exercising supervision, maintenance care of devices, administering medications and ointments, changing dressings laundering personal items and bedding, and fixing light meals. 42 C.F.R. § 409.33.
  5. Does Medicare pay for home care?
    Medicare does pay for home health care and there is no limit on how many 60 day “episodes” Medicare may cover. Please watch the ALS-MAP Webinar for coverage details.
  6. Can I use home health care hours for nights?
    Medicare coverage does not distinguish between “day” or “night” care. If an individual meets Medicare coverage criteria for the home health care services, the timing of those services should be discussed in the plan of care.
  7. Is therapeutic massage covered?
    Medicare does not cover the services of a massage therapist, but similar services may be a covered component of services that are provided by a physical therapist. See 42 C.F.R. § 409.33 (c) 1-8.
  8. Where does respiratory therapy fit into this?
    Skilled service? If a respiratory therapist is used to furnish overall training or consultative advice to a HHA’s staff and incidentally provides respiratory therapy services to beneficiaries in their homes, the costs of the respiratory therapist’s services are allowable as administrative costs. Visits by a respiratory therapist to a beneficiary’s home are not separately billable. However, respiratory therapy services that are furnished as part of a plan of care by a skilled nurse or physical therapist and that constitutes skilled care may be separately billed as skilled visits. 42 C.F.R. § 409.46 (c).
  9. Does Medicare pay for a home generator if electricity is needed for respiratory care in case of electrical outage?
    Medicare will not pay for a home generator. The definition of durable medical equipment (DME) for Medicare coverage includes equipment which is generally not useful to a person in the absence of an illness or injury. MBPM, Chapter 15 § 110.1. Since a home generator may be useful to a person in the absence of an illness or injury, it is not coverable by Medicare.
  10. Can home care patient be discharged due to a caregiver being educated?
    Educating a caregiver is a Medicare covered service. Teaching and training activities that require skilled nursing personnel to teach a patient, the patient’s family or caregivers how to manage the patient’s treatment regimen would constitute skilled nursing services. MBPM Chapter 7, § 40.1.2.3.
  11. Can someone say a caregiver is too old to be trained?
    No one can ever say a caregiver is too old to be trained. Age is not relevant. Where it becomes apparent, after a reasonable period of time, that the patient, family, or caregiver will not agree to be trained, or is not able to be trained, then further teaching and training would cease to be considered to be reasonable and necessary by Medicare.  MBPM Chapter 7, § 40.1.2.3.
  12. Who’s supposed to cover the incontinence briefs if patient is receiving home health services? 
    Medicare offers limited coverage of incontinence supplies for home health. Incontinence briefs are covered as a routine medical supply in the normal course of a visit. That means Medicare will cover incontinence supplies that home health staff use during their visits, but the home health agency (HHA) does not have to leave supplies in the home for use by the patient or family caregivers between home care visits. MBPM, Chapter 7 § 50.4.1.2.D.
  13. When an ALS patient is admitted into the hospital for pneumonia and is there for 3-5 days in the middle of a 60 day episode of home health services does the home health agency services stop and a new episode has to start when they are discharged?
    Home health coverage would be stopped during the hospitalization and restarted at discharge, assuming the 60 day home health episode had not ended. In the event a person is admitted to an inpatient facility and the inpatient stay overlaps into what would have been a subsequent episode and there is no new certification assessment of the patient, then the new certification begins with the new start of care date after the inpatient discharge. For these and other hospitalization examples, see MBPM, Chapter 7 § 10.10.H.
  14. Is the RN limited to 21 consecutive days or 21 visits?
    No, there is no durational limit on coverage for home health care. Assuming skilled nursing care is considered reasonable and necessary, it must be performed on a part-time or intermittent basis. 42 C.F.R. § 409.44(b). Part-time or intermittent means skilled nursing and home health aide services (furnished any number of days per week) as long as they are furnished (combined) less than 8 hours each day and 28 or fewer hours each week (or, subject to review on a case-by-case basis as to the need for care, less than 8 hours each day and 35 or fewer hours per week). MBPM, Chapter 7 §§ 40, 50.7.
  15. What are the qualifications of a skilled professional? Is a CNA considered skilled?
    For Medicare coverage purposes, care provided by a CNA is not considered to be skilled nursing care. Skilled nursing care consists of those services that must, under State law, be performed by a registered nurse, or practical (vocational) nurse. 42 C.F.R. § 409.44(b)(1). To be covered as skilled nursing services, the services must require the skills of a registered nurse or a licensed practical (vocational) nurse under the supervision of a registered nurse. MBPM, Chapter 7, §40.1. If all other eligibility and coverage requirements under the home health benefit are met, skilled nursing services are covered when an individualized assessment of the patient’s clinical condition demonstrate that the specialized judgment, knowledge, and skills of a registered nurse or, when provided by regulation, a licensed practical (vocational) nurse are necessary. MBPM Chapter 7, § 40.1.1.
  16. Both parts A and B provide coverage for Home Health care?
    Yes, Medicare Part A or Medicare Part B covers home health care. There is no difference in coverage type between Part A or Part B. To the extent that all coverage requirements are met, payment may be made on behalf of eligible beneficiaries under Part A for an unlimited number of covered home health visits. All Medicare home health services are covered under hospital insurance unless there is no Part A entitlement. 42 C.F.R. § 409.48(a). Medicare home health services are covered under Part B only when the beneficiary is not entitled to coverage under Part A. 42 C.F.R. § 209.48(b).
  17. Did not see RT (resp. therapy) as a triggering event but this would be very common with ALS patients. Can it be a trigger?
    Respiratory therapy is not a triggering event for Medicare Home Health care coverage. If a respiratory therapist is used to furnish overall training for consultative advice to a HHA’s staff and incidentally provides respiratory therapy services to beneficiaries in their homes, the costs of the respiratory therapist’s services are allowable as administrative costs. Visits by a respiratory therapist to a beneficiary’s home are not separately billable. However, respiratory therapy services that are furnished as a part of a plan of care by a skilled nurse or physical therapist and that constitute skilled care may be separately billed as skilled visits. 42 C.F.R. § 409.46 (c).
  18. Is there a limit to the number of hours w day/week/month to the homecare benefit?
    The unit of payment under the Home Health Prospective Payment System (HH PPS) is a national 60-day episode rate, with applicable adjustments. MBPM Chapter 7, § 10. HH PPS permits continuous episode re-certifications for patients who continue to be eligible for the home health benefit. Medicare does not limit the number of continuous episode re-certifications for beneficiaries who continue to be eligible for the home health benefit. MBPM, Chapter 7, § 10.3. For any home health services to be covered by Medicare, the patient must meet the qualifying criteria, including having a need for skilled nursing care on a part-time or intermittent basis, and/or physical therapy, and/or speech-language pathology services, and/or a continuing need for occupational therapy. The term “part-time or intermittent” for purposes of coverage means skilled nursing AND home health aide services furnished any number of days per week as long as they are furnished (combined) less than 8 hours each day and 28 or fewer hours each week (or, subject to review on a case-by-case basis as to the need for care, less than 8 hours each day and 35 or fewer hours per week) MBPM Chapter 7, § 40, § 50.7. 
  19. Medicare pays per visit not per hour?  How does this work?
    Medicare does not pay by hour or by visit. Medicare pays on a national 60-day episode rate with applicable adjustments. The law requires the 60-day episode to include all covered home health services, including medical supplies, paid on a reasonable cost basis. That means the 60-day episode rate includes costs for the six home health disciplines (skilled nursing services, home health aide services, physical therapy, speech-language pathology services, occupational therapy services and medical social services), the costs for routine and non-routine medical supplies, and therapies that could have been unbundled to Part B coverage prior to HH PPS. Adjustments to the 60-day episode rates are case-mix adjustments (clinical severity, functional severity, and service utilization) and labor adjustments by location. MBPM Chapter 7, § 10, 10.1(A) and (B).
  20. Does HHC supply enemas for a PALS bowel program?
    Medicare provides the following example, the condition of a patient…may be such that he or she can be given an enema safely and effectively only by a nurse. If the enema were necessary…, then the visit would be covered as a skilled nursing visit. The documentation must support the skilled need for the enema, and the plan for future visits based on this information. MBPM, Chapter 7, § 40.1.1 Example 2.
  21. Is an HHC company responsible for all medical supplies care needed? 
    For example – condom catheters? All costs for routine and non-routine medical supplies are included in the home health care 60-day episode rate. MBPM Chapter 7, §§ 10.1.A., 10.11.B.
  22. Is there a way for Medicare to reimburse a nurse/assistant who is NOT part of a home health care agency?
    Yes, under arrangement with the home health agency (HHA). For individuals under a home health plan of care, payment for all services and supplies, with the exception of osteoporosis drugs and durable medical equipment (DME), is included in the HH PPS base payment rates. HHAs must provide the covered home health services (except DME) either directly or under arrangement, and must bill for such covered home health services. Payment must be made to the HHA. MBPM Chapter 7, § 10.11. A HHA is responsible for payment in the situation in which services are provided to a patient by another entity, under arrangement with the HHA, during an episode in which the patient is under the HHA’s home health plan of care. MBPM Chapter 7, § 10.11.E.

“Homebound” Requirement

  1. What does homebound mean?
    The criteria to qualify for home health care includes being confined to the home, under the care of a physician, in need of skilled services, and under a plan of care. 42. C.F.R. § 409.42. The criteria to be confined to the home, or “homebound”, is typically analyzed in two steps. Step one states that the patient must have one of two circumstances: 1. Because of illness or injury, the patient needs the aid of a supportive device, such as crutches, cane, wheelchair or walker, or needs the use of special transportation, or needs the assistance of another person in order to leave their place of residence, or 2. The patient has a condition such that leaving his or her home is medically contraindicated (such as being medically fragile or medically compromised). Step 2 states that there must exist a normal inability to leave the home AND leaving home must require a considerable and taxing effort. If a patient does in fact leave the home, the patient may nevertheless be considered homebound if the absences from the home are infrequent or for periods of relatively short duration, or are attributable to the need to receive health care treatment. MBPM, Chapter 7 § 30.1.1.
  2. Am I understanding that an ALS patient cannot receive home care assistance (for personal hygiene help) if they are in a wheelchair and leaving the home trying to lead a normal social existence?
    The answer to this question requires more analysis of the individual’s situation, and likely will turn on the person’s “normal inability to leave the home”. Occasional absences from the home for non-medical purposes, e.g. an occasional trip to the barber, a walk around the block or a drive, attendance at weekly faith services, a family reunion, funeral, graduation, or other infrequent or unique events would not necessitate a finding that the patient is not homebound if the absences are undertaken on an infrequent basis or are of relatively short duration and do not indicate that the patient has the capacity to obtain the health care provided outside rather than in the home. MBPM, Chapter 7 § 30.1.1
  3. In regard to home health coverage, could it be discontinued if PALS takes a vacation with equipment and taxing effort but not a specialized vacation/destination such as the cruise you spoke of your in your example?
    This would likely be allowed. The absence would be considered “an infrequent basis”. It would be important to document why there is a considerable and taxing effort, the supportive devices and the assistance of others used, the provisions made to ensure there is a plan for what would happen in the event of a medical emergency. It would also be helpful to indicate the level of “participation” the patient had in the vacation activities (or lack of participation), and how much the patient rested during the trip.
  4. If an ALS patient qualifies as homebound and the doctor writes a care plan to have a RN visit once a month to check the status of the patient and includes a home health aide 4 x per week at 3 hours per visit does any other service need to be added?
    I guess the true question is can a HHA be the main service that the pt. is receiving? Yes, again assuming the person is confined to the home, under the care of a physician, in need of skilled services, and under a plan of care, in this particular scenario, Medicare should approve coverage. Orders for care may indicate a specific range in the frequency of visits to ensure the most appropriate level of services is provided during the 60-day episode to home health patients. See MBPM, Chapter 7 § 30.2.2. The skilled nursing (at one visit a month), and the home health aide (at a total of 12 hours a week) is “intermittent” as it is furnished less than 8 hours each day and 28 or fewer hours each week. See MBPM, Chapter 7 §§ 40, 50.7.
  5. Does Medicare cover Physical Therapy for a patient that is not homebound? 
    Yes. But not under the home health care benefit. Physical therapy is a covered Part B service. Evaluations and treatment for an injury or disease that changes a person’s ability to function are usually covered. A doctor or other health care provider must certify the need for physical therapy. There is usually a limit of $1,960 per year, but there may be some exceptions to these limits. Physical therapy covered as a Part B benefit is subject to the Part B deductible and 20% co-insurance.
  6. Does it matter how many times I leave the home per week or where I go – outside of Dr, ADC?  Example – Grocery, Post Office, Library, Going out to lunch.
    Medicare has no “rules of thumb” about how many times a week someone leaves their home or where they go. All of an individual’s circumstances will be considered. Leaving the home for health care treatment is the most “appreciated” reason for leaving the home (Medicare also notes attendance at adult day centers to receive medical care is acceptable). Going to the grocery store, post office and library infrequently or for periods of short duration are usually acceptable. If someone is leaving their house every day of the week for non-medical reasons, Medicare may (or may not) say that demonstrates a “normal ability to leave home” even if it does require a considerable and taxing effort and assistance. There are no cut-and-dried answers, but duration and distance should be taken into consideration.

Specific Coverage Questions

  1. You mentioned that a home health aide can be paid for by Medicare through a supervising HHA under an arrangement.  I have an aide I am paying for privately now.  I am getting skilled nursing, bath aide, PT and ST therapy from an HHA provider now. I have been trying to get my aide paid for by Medicare through the HHA and they have been non-cooperative in either hiring her directly and also saying home health aide coverage is only for bath aide.
    It sounds like you are saying she can be paid through Medicare WITHOUT having to go to work for them….is this what you are saying? Can you please explain this in more detail? Once a patient elects to receive home health coverage, payment for all services and supplies is included in the payment rate for the episode. MBPM Chapter 7, § 10.11. A patient may ask the HHA to make “arrangements”, such as a contract service, with someone who is not their employee. But they are not required to contract with the individual. The HHA’s consolidated billing role supersedes all other billing situations the beneficiary may wish to establish for home health services covered under the scope of the Medicare home health benefit during the certified episode. MBPM Chapter 7, § 10.11.D. If the HHA is saying that home health aide coverage is only to aide in bathing, this is incorrect. A home health aide generally is covered for personal care services which may include assistance in dressing, eating (not tube feeding, which is considered a skilled task), toileting, bathing, positioning, exercising supervision, maintenance care of devices, administering medications and ointments, changing dressings laundering personal items and bedding, and fixing light meals. 42 C.F.R. § 409.33.
  2. I contacted my Neurologist about a skilled nurse for my bedsore, a PT for range of motion, and a home health aide to help me in toileting. The PT is telling me that she can see me for a month or two and then it ends.  Medicare demands that the PT has a goal for progress not just maintenance.  Medicare wants her to train someone to continue the PT.  My caregiver is my ex.  She is a breast cancer survivor and had a mastectomy.  She has trouble moving me.  The aides will only come when they have an opening, not when I need someone to help me go to the bathroom.  What can I do?
    Each of the issues (skilled care to assess and treat bedsore, PT for range of motion, and home health aide for toileting) are all included for Medicare coverage. The PT is incorrect in stating you have any durational limit for PT coverage. As long as there is a need for PT services, including range of motion, to maintain the current condition or to prevent or slow further deterioration, no improvement or “progress” is required. Coverage of skilled nursing care or therapy to perform a maintenance program does not turn on the presence or absence of a patient’s potential for improvement from the nursing care or therapy, but rather on the patient’s need for skilled care. The plan of care will require that there be “goals” but “goals” may be defined as maintaining the patient’s current condition or preventing or slowing further deterioration of the patient’s condition. MBPM Chapter 7, § 20.1.2. As for the toileting, your Medicare coverage will extend for home health aides as long as they are furnished (along with skilled nursing, combined) less than 8 hours each day and 28 or fewer hours each week (or, subject to review on a case-by-case basis as to the need for care, less than 8 hours each day and 35 or fewer hours per week). MBPM Chapter 7, § 40, 50.7. Assuming it is 35 hours, the HHA bills Medicare for the skilled nursing and home health aide services, which were provided by the 35th hour of service each week, and bills the beneficiary (or another payer) for the remainder of the care (up to 24 hours per day, 7 days per week for the home health aide). MBPM Chapter 7, § 50.7.1.
  3. Can the home health care agency limit coverage when they are wanting to go to a maintenance program for the ALS patient and reduce the PT, OT, and Home Health Aide services when the primary care physician has written a prescription for the services to continue as they have always been so that the patient maintains the most function as ALS changes?
    In most circumstances, no. Medicare recognizes that determinations of whether home health services are reasonable and necessary must be based on an assessment of each beneficiary’s individual care needs. MBPM Chapter 7, § 20.3. The plan of care must include a course of treatment for therapy services with measureable treatment goals, expected duration of therapy services, and description of a course of treatment which is consistent with the qualified therapist’s assessment of the patient’s function. MBPM Chapter 7, § 30.2.1. There is no difference in coverage afforded to a patient based on maintenance versus improvement. It is based only on objective clinical evidence regarding the patient’s individual need for care. Coverage of skilled nursing care or therapy to perform a maintenance program does not turn on the presence or absence of a patient’s potential for improvement from the nursing care or therapy, but rather on the patient’s need for skilled care. The plan of care will require that there be “goals” but “goals” may be defined as maintaining the patient’s current condition or preventing or slowing further deterioration of the patient’s condition. MBPM Chapter 7, § 20.1.2.                  
  4. I am getting OT, an RN once a week, an LVN once a week and an aide 3 days a week.  Should I be able to have an aide 5 days a week?  I have lost use of left hand, am now losing right.
    Medicare coverage for the RN, LVN and aide (combined, as long as they are furnished), are for less than 8 hours each day and 28 or fewer hours each week (or, subject to review on a case-by-case basis as to the need for care, less than 8 hours each day and 35 or fewer hours per week). MBPM Chapter 7, § 40, 50.7. Assuming it is 35 hours, the HHA bills Medicare for the skilled nursing and home health aide services, which were provided by the 35th hour of service each week, and bills the beneficiary (or another payer) for the remainder of the care (up to 24 hours per day, 7 days per week for the home health aide). MBPM Chapter 7, § 50.7.1.
  5. I was told by a home health company that since I was not showing improvement, they were not set up to just to provide maintenance.  They said they would lose their Medicare license.  Also said it was to be for only a short time i.e. 30 days. PT told me to do it myself. Who can I talk to get help?
    Perhaps either through your local ALS Association Chapter or family or friends, you should contact other Medicare certified HHA to see if any of the other HHAs understands that coverage for “maintenance” of your condition is as equally coverable by Medicare as it is for someone who might be expected to improve.
  6. What happens if a patient initially requires skilled services and qualifies for a home care aide but then the skilled services are no longer needed but a home health aide is needed?
    To receive Medicare coverage for home health services, some type of skilled care is always required. The skilled care may be nursing care (must be reasonable and necessary, intermittent, and not solely needed for venipuncture for the purposes of obtaining blood sample). Or the skilled care may be physical therapy, speech-language pathology services, or occupational therapy (a continuing need). MBPM Chapter 7, § 30.4. Home health aide alone is not a covered service.
  7. What if HH (PT) requires you to sign an ABN because “they” think Medicare will not cover it?  And if the claim is denied will I have to pay HH – during claim appeal?
    Refer to the Self-Help Packet for Home Health Care Appeals. Beneficiaries in traditional Medicare have a legal right to an Expedited Appeal when home health providers plan to discharge them or discontinue Medicare-covered skilled care. (Note: An Expedited Appeal is not triggered when the provider lowers the frequency of skilled care.) To try to prevent the discontinuation of Medicare Covered Care, call the telephone number for the Quality Improvement Organization listed on your notice no later than noon of the calendar day following the receipt of the notice. Remember that Medicare only pays for care that has been provided, not care that “should” have been provided. In the event that the Expedited Appeal fails and you continue to receive care, you should ask the HHA to put a bill into the Medicare system to see if Medicare will pay for the services you received.
  8. My wife is on a ventilator and cannot be left alone. What kind of care is covered?
    Ventilator Care is considered a skilled service. Teaching of any service otherwise defined as skilled is also a skilled service. Administration of medical gases and fall prevention and home safety issues taught to a patient or the patient’s family/caregiver are coverable home health services. Medicare does not pay for 24-hour home care. If skilled nursing needs are full-time and not intermittent, an individual may qualify for Medicare home care coverage based on the need for other covered skilled care (physical therapy, speech-language pathology, or continuous occupational therapy). Once a person qualifies for any skilled, home health coverage may also include the personal care services of a home health aide for less than 8 hours each day and 28 or fewer hours each week (or, subject to review on a case-by-case basis as to the need for care, less than 8 hours each day and 35 or fewer hours per week). MBPM Chapter 7, § 40, 50.7.
  9. If you are on a ventilator and paralyzed, don’t you always need a skilled nurse?
    Medicare states that a service, by its nature, requires the skills of a nurse to be provided safely and effectively, continues to be a skilled service even if it is taught to the patient and the patient’s family or other caregivers. MBPM Chapter 7, § 40.1.1.  Medicare considers all the following to be skilled services medically necessary as associated with ventilator care: 1. Ventilator management and evaluation and assessment for changes in the patient’s condition, particularly in situations where the patient’s respiratory status is unstable and may change suddenly and unpredictably, and require medical treatment; 2. Ventilator management includes changes in settings, ventilator maintenance, and cleaning of internal ventilator components; 3. Initiation of and changes in regimens involving administration of medical gases; 4. Insertion and replacement of tracheal cannula; and 5. Active weaning of ventilator dependent individuals.
  10. Will the benefit cover someone who is in a clinical trial and requires injections because of the trial?
    Please refer to the brochure “Medicare and Clinical Research Studies” to understand Medicare coverage for an individual who chooses to participate in a clinical trial. https://www.medicare.gov/Publications/Search/results.asp?PubID=02226PubLanguage=1Type=PubID

Center for Medicare Advocacy Submits Comments on Proposed MACRA Rule

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The Center for Medicare Advocacy submitted comments this week to the Centers for Medicare Medicaid Services (CMS) concerning the proposed rule on the Medicare Program Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule (CMS–5571–P), two elements proposed in the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

The Center’s overarching comments for both MIPS and Advanced APMs touched on risk adjustment for socio-economic status and on the importance of outcome measures that meet individually assessed needs. Regarding MIPS, the Center commented that the proposal gives too much latitude to clinicians to choose measures that they can meet without having to demonstrate that they assess the needs of the individual patient. Overall the Center hopes that the MIPS category can become more meaningful, more evidence-based, and better positioned to promote better patient health outcomes.

Regarding Advanced APMs, given the great flexibility afforded to existing entities that qualify for Advanced APM status under the proposed rule, the Center recommends that CMS offer patient advocacy groups greater input into the design of Advanced APM measures, payments, and informational materials sent to beneficiaries. We also encourage CMS to require entities applying to become Advanced APMs in the future to use clinical care models that results in improved delivery of care, such as the Medical Home Models.

The Center’s comments are available at http://www.medicareadvocacy.org/center-comments-on-proposed-changes-to-physican-payments/.

Organizing for Comprehensive Oral Health Care

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As part of the Center for Medicare Advocacy’s commitment to improving oral health for older people and people with disabilities, Center attorneys recently attended a DentaQuest convening in Cambridge, Massachusetts aimed at unifying partners in this common mission. The convening focused on leadership strategies, shared network goals and collaborative work in social justice.  The Center’s work of developing a comprehensive oral health benefit in Medicare is a crucial component of this larger mission.  The Center for Medicare Advocacy is pleased to be working with the DentaQuest Foundation to advance their goal of adding a comprehensive oral health benefit to Medicare. 

DentaQuest is growing a national network around the concept of oral health as a social justice issue, with the mission of achieving oral health for all by 2020. The Center is pleased to join this network. The Center will have the opportunity to work collaboratively with other DentaQuest “change agents” on DentaQuest’s Oral Health 2020 mission, particularly on the goal of including an adult dental benefit in publicly funded health coverage. DentaQuest’s Oral Health 2020 “is a multi-year effort to strengthen and unify the network, build upon current initiative strategies, and expand impact. The time is right to bring about lasting systems change through the power of collective action. [DentaQuest is] engaging grantees and partners around a set of bold, shared goals with specific targets to be achieved by 2020.”

The Center’s ongoing work will focus on the urgent need for medically essential oral health coverage, while expanding the broader effort to push for comprehensive Medicare coverage for oral health care, including preventive services. We will continue partnering with DentaQuest, Retirement Research Foundation, Oral Health America, and other medical and advocacy partners to move this issue forward.

Research demonstrates that oral health disparities exist for many racial and ethnic groups, by socioeconomic status, gender, age and geographic location. This underscores the need to approach oral health disparities as a component of social justice. DentaQuest supports an approach to policy changes in oral health that respond to the social determinants of health. DentaQuest recognizes that, in order to make strides in health equity, it is essential to address the disparities that are at the root of the problem.

The Center is currently working to ensure beneficiaries who need non-routine, medically essential oral health care can obtain Medicare coverage for this essential care. Denying Medicare coverage to people for medically essential care, simply because it involves the mouth or teeth, is a misapplication of current law. It causes harm to older and disabled people, impeding their access to other critical health care and even leading to preventable deaths. The Center is eager to continue working on this crucial component of overall health.

While the Center will continue longstanding work to ensure Medicare coverage of medically essential oral health needs, we are also eager to help lead major national initiatives to develop a robust oral health benefit in Medicare that includes preventive care.

More information on DentaQuest is available at http://dentaquestfoundation.org/oh2020

June 29, 2016 – K. Kertesz

Medicare Part D and Off-Label Rx Denials

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In the last 18 months, the Center for Medicare Advocacy, and other advocates around the country, have received many, many calls from older and disabled beneficiaries who can no longer obtain coverage for the Lidocaine Patch 5% from their Part D plans. Many have been using the Patch for at least a decade and are devastated when cut off from their primary source of pain relief for lack of a “medically accepted indication.”  The abrupt increase in denials of the Patch, beginning in 2015, is undoubtedly due to pressure from CMS to curtail coverage for off label drugs.

In order to be covered under Part D, drugs must be prescribed for a “medically accepted indication,” meaning their use for a particular disease must be approved by the FDA, or supported by one of three largely inaccessible Compendia, identified at Section 1927(g)(1)(B)(i) of the Social Security Act.  (The Act was subsequently modified to allow coverage of anti-cancer drugs if their use is supported in peer review journals.  Note that under Part B, all drugs, not just those used in an anti-cancer regimen, may be supported by peer reviewed literature.)

The Lidocaine Patch 5% is FDA approved for post hepatic neuralgia (shingles pain) and one of the compendia also approves it for diabetic neuropathy.  It is a highly effective pain reliever and its unique non-narcotic and non-addictive properties make it a benign alternative to opioids, without the risks and devastating side effects of opioids.[1] One out of every five drugs in the US is prescribed off-label; the Patch is often prescribed off-label to treat pain from spinal stenosis, degenerative disc disease, and severe osteoarthritis.

The fact that CMS is pushing Part D plans to deny coverage of the non-narcotic pain reliever Lidocaine Patch 5%, when the nation is facing a massive opioid crisis, seems misguided at best.  CMS’s efforts are undoubtedly an attempt to save money and bring plans into compliance with federal law that prohibits coverage of off-label drugs under Part D, but this action has had devastating consequences on many older and disabled Medicare beneficiaries. Without Part D coverage, most cannot afford to pay for the Patch out-of-pocket and have little choice but to rely on opiates for pain relief.

And by the way… should one of those individuals become addicted to opiates, and later require drug abuse treatment, the bad news is that Medicare doesn’t cover methadone maintenance therapy either!

Coverage denials for Lidocaine and other off-label drugs can be a shock and pose a major problem for people who become Medicare eligible and must transition from an Affordable Care Act (ACA) or a private insurance plan. When coverage has long been available based on their physician’s prescription, and that prescription is suddenly no longer available, these individuals lose access to effective medications. This results in confusion and harm to patients who can no longer get their medication – as well as dissatisfaction with Medicare, and contention between patients and providers. The discrepancy between coverage standards needs to change. Part D should use the same coverage standards as ACA. At the very least, Part D standards should not be more restrictive than Part B.

June 29, 2016 – J. Watrous

Center Comments on Proposed Hospice Rates and Requirements

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June 20, 2016

Andrew Slavitt, Acting Administrator
Centers for Medicare Medicaid Services
Department of Health Human Services
Attention: CMS–1652–P
P.O. Box 8010
Baltimore, MD 21244-8010

Re: CMS–1652–P

Dear Mr. Slavitt:

The Center for Medicare Advocacy (Center) is pleased to provide the Centers for Medicare Medicaid Services (CMS) comments on its proposal “Medicare Program; FY 2017 Hospice

Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements” (81 Fed. Reg. 25498) published on April 28, 2016. The Center, founded in 1986, is a national, non-partisan education and advocacy organization that works to ensure fair access to Medicare and to quality health care. At the Center, we educate older people and people with disabilities to help secure fair access to necessary health care services. We draw upon our experience of working with thousands of individuals to educate policy makers about how their decisions affect access to services.  Additionally, we provide legal representation to ensure that people receive the health care benefits to which they are legally entitled, and the quality health care they need.

We address the following in our comments:

  • proposed quality measures; and
  • Hospice Compare website.

Introduction to Comments

Hospice care is holistic care for the dying as well as emotional and educational support for their caregivers. Hospice became a Medicare benefit in 1983 and is available to those who have been diagnosed with a limited life expectancy of six months or less. Once a patient elects hospice, the hospice provider creates a plan of care that “includes all services necessary for the palliation and management of the terminal illness and related conditions.”[1]

Proposed Quality Measures

The Center supports the two proposed quality measures described in the proposed rule that would begin in FY 2017. Both are composite measures.

The first composite measure looks at the number of visits when death is imminent: 1) the number of patients who receive at least two visits from clergy, social workers, spiritual counselors, licensed practical nurses, or hospice aides during their last seven days of life and 2) the number of  patients who receive at least one visit from a physician during their last three days of life.[2] The Center believes this composite score can improve the quality of comfort care and caregiver support to patients during their final days. Skilled care may be necessary during the patient’s final days because, in part, skilled nurses can teach caregivers not only how to administer pain and anxiety drugs, but also how to care for the unique needs of the patient as his or her body begins to shut down. As noted by MedPAC in its May 31, 2016 comments on the hospice proposed quality measures, “a very important function of hospice is to provide appropriate clinical and psychosocial support throughout a patient’s hospice stay. Therefore, we believe quality measures that gauge the extent to which hospices are providing visits to patients in their last days of life are valuable.”[3]

According to a spring 2014 Abt Associates report commissioned by CMS that relied on all hospice data submitted in 2012, over 53,000 hospice patients (around nine percent out of a total of 585,648 beneficiaries) who received routine home care did not receive a visit from skilled hospice staff during their last three days of life.[4] Additionally, a total of 189,000 patients who received routine home care (28.9 percent out of a total of 656,355 patients) in 2012 did not receive a skilled visit on their last day of life.[5] Further, patients who died on a weekend were more likely than patients who died on a weekday to have gone without a skilled visit during their final days.[6] The Abt Associates report surmises that the large percentage of beneficiary deaths can be “partially explained by beneficiaries dying suddenly or unexpectedly where a hospice would not be able to send out a staff person in time to perform a visit.”[7] Routine home care patients can receive up to eight hours of hospice care a day. Given that 97.7 percent of hospice billing in 2014 was coded as routine home care, it is critical that routine home care patients have access to Medicare’s hospice services during their final days of life.[8] While we support this measure, we encourage CMS to recognize that the patient or the family may wish to decline a visit from a physician, clergy member, social worker, etc. in the last days of the patient’s life. In short, a patient’s wish to decline visits from providers of services during these last days should  not count against the hospice agency. Additionally, CMS should be sensitive to creating incentives that drive visits for the sake of visits rather than quality of care.

The Center also supports the proposed composite measure that aggregates a hospice’s performance across all seven Hospice Item Set (HIS) quality measures at admission. These seven process measures are the following: addressing the patient’s beliefs and spiritual values (if desired), pain assessment, pain screening, dyspnea screening, dyspnea treatment, documentation of treatment preferences, and provision of bowel regimen for patients receiving an opioid.[9] [10] This composite assessment would provide a holistic score upon which prospective patients could evaluate hospices on Hospice Compare. Currently, hospice providers already make an assessment at admission using the seven existing HIS quality measures, but a composite score provides a new score with which to holistically measure the hospice. CMS states that a composite measure better guarantees that all of these assessments are conducted at admission.[11] The proposed rule states: “Collecting information about the total number of care processes conducted for each patient will incentivize hospices to conduct all desirable care processes for each patient and provide services that will address their care needs and improve quality during the time he/she is receiving hospice care.”[12]  The Center hopes, however, that this assessment does not delay the delivery of necessary services for patients and their families.

The Center agrees with the suggestions of MedPAC that CMS should in the near future develop hospice outcome measures in order to further guarantee that quality care and assessments are being delivered to patients.[13] One of the major challenges to implementing hospice outcome measures is the short duration of many hospice stays. A January 2016 JAMA article’s authors interviewed close family and friends of deceased hospice and non-hospice patients and found that survivors were more likely to report excellent end-of-life care when patients received hospice care for more than three days (58.8 percent of those surveyed) than those who received fewer hospice days or did not elect hospice at all.[14] The study shows that assessing the outcomes of bereavement and palliative services among patients and loved ones in hospice throughout a hospice stay could provide hospices with valuable data concerning the benefits of providing certain services.

Hospice Compare

The proposed rule also offers more descriptive details concerning the Hospice Compare website. The Center supports CMS’ progress towards the creation of a tool prospective hospice patients can use to evaluate hospice providers.

It’s unclear, however, how much correction CMS will allow hospices when it states in the proposal its desire to give providers the opportunity to “review and correct data they submit on all measures that are derived from the HIS.”[15] If the HIS records errors that have not been submitted, CMS claims that the provider’s correction process is not uniform and depends on the type of error. Concerning modification requests to already-submitted HIS data, CMS states that only the following things cannot be modified: admission date, discharge date, and basic demographic information such as the patient’s Social Security number and date of birth.[16] If providers can modify anything other than clerical errors and substantively change the quality scores of the seven HIS measures, the Hospice Compare website might not offer accurate and useful information to consumers.

All seven Hospice Item Set measures consist of self-reported data.[17] In order to augment such self-reported data, we support timely inclusion of CAHPS survey data into Hospice Compare. Such a measure could mitigate against gaming by providers. One high profile investigation in August 2014 by the New York Times shows, for instance, how Medicare-participating nursing homes have in recent years modified their facility-reported assessment (MDS) data in order to alter their star ratings on the Nursing Home Compare website.[18] Given the increased incentives to modify HIS quality measures inherent in the display of these measures on the Hospice Compare site, the Center would hope that CMS would conduct more audits of hospices to ascertain the accuracy of provider reports. While the IMPACT Act requires that an inspector audit a hospice at least every three years, an increased number of audits can better guarantee that Hospice Compare meet the following goal stated by CMS in its  proposed rule : “It is essential that the data made available to the public be meaningful.”[19]

Conclusion

The Center for Medicare Advocacy appreciates the opportunity to provide comments on the proposed rule.  For further information, please contact Center Senior Policy Attorney David Lipschutz at dlipschutz@medicareadvocacy.org, 202-293-5760.

Sincerely,

Matthew Hubbard
David Lipschutz


[1] 42 C.F.R. § 418.56(c).
[2] CMS. “Proposed Hospice Quality Measures and Information Collection Methods.” 28 April 2016. https://www.gpo.gov/fdsys/pkg/FR-2016-04-28/pdf/2016-09631.pdf  (site visited June 14, 2016). P. 25522. CMS. “Hospice Quality Reporting Program: Specifications for the Hospice Item Set-Based Quality Measures.” April 2016. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/HQRP-Specifications-for-HIS-based-Quality-Measures.pdf (site visited June 16, 2016). P. 43.
[3] Medicare Payment Advisory Commission. “MedPAC Comment on CMS’s Proposed FY 2017 Hospice Payment Rate Update and Hospice Quality Report Requirements.” 31 May 2016. http://medpac.gov/documents/comment-letters/medpac-comment-on-cms’s-proposed-fy-2017-hospice-payment-rate-update-and-hospice-quality-report-requirements.pdf?sfvrsn=0 (site visited June 14, 2016). P. 2.
[4] Abt Associates. “Medicare Hospice Payment Reform: Analyses to Support Payment Reform.” 01 May 2014. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Downloads/May-2014-AnalysesToSupportPaymentReform.pdf (site visited May 17, 2016). P. 62.
[5] Ibid.
[6] Ibid. P. 63.
[7] Ibid. P. 62.
[8] Medicare Payment Advisory Commission. “March 2016 Report to the Congress: Medicare Payment Policy.” March 2016. http://medpac.gov/documents/reports/chapter-11-hospice-services-%28march-2016-report%29.pdf?sfvrsn=0 (site visited May 17, 2016). P. 302.
[9] CMS. “Proposed Hospice Quality Measures and Information Collection Methods.” P. 25524-5.
[10] While CMS states that the Hospital Item Set “is not a patient assessment instrument and will not be administered to the patient and/or family or caregivers” and that an “item set is a standardized mechanism for abstracting data from the medical record,” CMS seems to be using the HIS in this composite measure as an assessment instrument. CMS uses the word “assess” to describe the function of this composite measure. See: CMS. “Fact Sheet: The Hospice Item Set (HIS).” https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/hospice-quality-reporting/downloads/his-fact-sheet.pdf (site visited June 16, 2016). CMS. “Proposed Hospice Quality Measures and Information Collection Methods.” P. 25524.
[11] CMS. “HIS Manual: Guidance Manual for Completion of the Hospice Item Set (HIS).” Effective July 1, 2014. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Downloads/HIS-Manual.pdf (site visited June 17, 2016).  P. 7.
[12] CMS. “Proposed Hospice Quality Measures and Information Collection Methods.” P. 25524-5.
[13] Medicare Payment Advisory Commission. “MedPAC Comment on CMS’s Proposed FY 2017 Hospice Payment Rate Update and Hospice Quality Report Requirements.” P. 3.
[14] Alexi A. Wright, Nancy L. Keating, John Z. Ayanian, Elizabeth A. Chrischilles, et. al. “Family Perspectives on Aggressive Cancer Care Near the End of Life.” JAMA. January 2016. P. 288-90.
[15] CMS. “Proposed Hospice Quality Measures and Information Collection Methods.” P. 25533.
[16] Centers for Medicare and Medicaid Services Hospice Quality Reporting Program. “Guidance Manual for Completion of the Hospice Item Set (HIS).” Effective July 1, 2014. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Downloads/HIS-Manual.pdf (site visited June 16, 2016). P. 67-8.
[17] CMS. “Hospice Quality Reporting Program: Specifications for the Hospice Item Set-Based Quality Measures.” P. 36-40. 
[18] Katie Thomas. “Medicare Star Ratings Allow Nursing Homes to Game the System.” The New York Times. 24 August 2014. http://www.nytimes.com/2014/08/25/business/medicare-star-ratings-allow-nursing-homes-to-game-the-system.html?_r=0 (site visited June 16, 2016).
[19] “Improving Medicare Post-Acute Care Transformation Act of 2014.” Public Law 113-185. 06 October 2014. https://www.gpo.gov/fdsys/pkg/PLAW-113publ185/pdf/PLAW-113publ185.pdf (site visited June 16, 2016). P. 18. CMS. “Proposed Hospice Quality Measures and Information Collection Methods.” P. 25532.

 

Center Comments on Medicare Reimbursement for Skilled Nursing Facilities

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June 20, 2016

Andrew M. Slavitt
Acting Administrator
Centers for Medicare Medicaid Services
Department of Health and Human Services
Room 445-G, Hubert H. Humphrey Building
200 Independence Ave., S.W.
Washington, D.C.  20201

Re: CMS-1655-P, Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities Proposed Rule for FY2017, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, and SNF Payment Models Research; Proposed Rule

Submitted electronically: http://www.regulations.gov

Dear Mr. Slavitt and CMS Colleagues:

The Center for Medicare Advocacy (Center) is a national, private, non-profit law organization, founded in 1986, that provides education, analysis, advocacy, and legal assistance to assist people nationwide, primarily the elderly and people with disabilities, to obtain necessary health care, therapy, and Medicare.  The Center focuses on the needs of Medicare beneficiaries, people with chronic conditions, and those in need of long-term care and provides training regarding Medicare and health care rights throughout the country.  It advocates on behalf of beneficiaries in administrative and legislative forums, and serves as legal counsel in litigation of importance to Medicare beneficiaries and others seeking health coverage.  These comments are based on our experiences talking with and representing hundreds of Medicare beneficiaries and their families who have been caught in observation status.

First, we oppose increasing Medicare rates paid to skilled nursing facilities (SNFs).  The Medicare Payment Advisory Commission (MedPAC) has reported that SNFs are overpaid by the Medicare program and have enjoyed Medicare margins exceeding 10% for 15 consecutive years.  In 2014, Medicare margins were 12.5%.  MedPAC recommends no increase in the Medicare rates for SNFs for FY 2016 and we agree.  MedPAC, Comments on CMS-1645-P (May 26, 2016), http://medpac.gov/documents/comment-letters/052516_cms_snf_comment_letter.pdf?sfvrsn=0; MedPAC, Report to the Congress: Medicare Payment Policy, Chapter (skilled nursing facility services), p. 172, (May 2016, http://medpac.gov/documents/reports/march-2016-report-to-the-congress-medicare-payment-policy.pdf?sfvrsn=2

Second, as we have recommended in previous years, we urge the Centers for Medicare Medicaid Services (CMS) to develop a nursing home-specific wage index.  Medicare overpays SNFs by using the hospital wage index.  CMS has had the authority since 2000, under §315 of the Medicare, Medicaid and SCHIP Benefits Improvement Act of 2000, to establish a geographic reclassification procedure specific to SNFs, using a SNF wage index.  We are not persuaded by CMS’s comment in the preamble to the proposed rules that “the volatility of existing SNF wage data and the significant amount of resources that would be required to improve the quality of that data” make it “unfeasible” to establish an appropriate wage index for SNFs.  81 Fed. Reg., 24237. 

Consolidated Billing

CMS takes a restricted view of drugs that should be excluded from consolidated billing.  81 Fed. Reg., 24242-24243.  The Center hears from Medicare beneficiaries who are denied admission to SNFs because of the high charges for drugs they need.  We urge CMS to do a careful analysis of drug costs to determine whether additional drugs should be excluded from consolidated billing.

SNF Value-Based Purchasing Program

Section 215 of the Protecting Access to Medicare Act of 2014 required establishment of a value-based purchasing program for SNFs.  The provision requires the Secretary to specify an all-cause all-condition hospital readmission measure.  Reducing unnecessary rehospitalization is its explicit goal and purpose.

CMS needs to avoid the pitfalls of its prior value-based purchasing initiatives in SNFs, which were not successful.  An analysis of the CMS demonstration of VBP in skilled nursing facilities between 2009 and 2012 found that VBP “did not directly lower Medicare spending and improve quality for nursing home residents.”  LM Policy Research, Evaluation of the Nursing Home Value-Based Purchasing Demonstration, page 50, Contract No. HHSM-500-2006-0009i/TO 7, http://innovation.cms.gov/Files/reports/NursingHomeVBP_EvalReport.pdf.

Concern about reducing rehospitalization as an independent goal

Before discussing the specific components of the proposed rule, the Center addresses concerns about encouraging a reduction in rehospitalizations, as an independent goal, without recognizing that some hospitalizations are necessary. 

Writing in The New England Journal of Medicine, Joseph G. Ouslander, M.D. and Robert A. Berenson, M.D. recognize the high cost of unnecessary hospitalization of nursing home residents and support the reduction of such hospitalization, but they add a cautionary note:

Multifaceted strategies will be needed to address the current incentives for hospitalization if we are to improve nursing home care and prevent unnecessary hospitalizations, with their related complications and costs. Two caveats are critical. First, not all hospitalizations for conditions that can theoretically be managed outside an acute care hospital are preventable. Second, given fiscal constraints and the dearth of health care professionals trained in geriatrics and long-term care, not all nursing homes have the capacity to safely evaluate and manage changes in the condition of the clinically complex nursing home population. Setting unrealistic expectations and providing incentives to poorly prepared nursing homes to manage such care rather than transferring residents to a hospital could have unintended negative effects on the quality of care and health outcomes.

Joseph G. Ouslander and Robert A. Berenson, “Reducing Unnecessary Hospitalizations of Nursing Home Residents,” N Engl J Med 2011; 365:1165-1167 (Sep. 29, 2011), http://www.nejm.org/doi/full/10.1056/NEJMp1105449.

Dr. Ouslander developed a tool, INTERACT II (Interventions to Reduce Acute Care Transfers), that can carefully and successfully reduce unnecessary hospitalization of nursing home residents.  Joseph G. Ouslander, M.D., et al, “Interventions to Reduce Hospitalizations from Nursing Homes: Evaluation of the INTERACT II Collaborative Quality Improvement Project,” The Commonwealth Fund (April 26, 2011), http://www.commonwealthfund.org/Publications/In-the-Literature/2011/Apr/Reduce-Hospitalizations-Nursing-Homes.aspxSee also Ouslander, “Improving Geriatric Care by Reducing Potentially Avoidable Hospitalizations,” http://www.avoidreadmissions.com/wwwroot/userfiles/documents/43/ouslander-interact-presentation-for-ny-ipro-webcast-jan-19-2011.pdf

However, “the goal of INTERACT is to improve care quality, not to prevent all hospital transfers” and INTERACT “can result in more rapid transfer of residents who need hospital care” (bold font and italics in original, slide 16).  INTERACT’s goals are to avoid hospitalizations that should be avoided and to support hospitalizations that are medically necessary. 

We have several specific concerns about reducing hospitalizations as a free-standing goal.

1. If nursing homes are encouraged not to hospitalize residents, many residents who need hospital care will be endangered.  Under contract with CMS, the Center analyzes nursing home decisions of the Departmental Appeals Board, both the Civil Remedies Division and the Appellate Division, and prepares a monthly report and searchable database.  Over the past 10 years of the contract, the Center has never seen a case involving inappropriate hospitalization of a resident, but has read many cases where a facility was sanctioned for failing to contact a resident’s physician and hospitalize a resident who needed to be hospitalized.

2. Numerous studies show that improving staffing levels in nursing homes can reduce the perceived (and actual) need to hospitalize nursing home residents.  Dr. Ouslander’s INTERACT II tool demonstrates the need for better staffing as do additional studies cited in the Center’s Weekly Alerts: “Reducing Rehospitalizations . . . The Right Way” (March 1, 2012), http://www.medicareadvocacy.org/reducing-rehospitalizations%e2%80%a6-the-right-way/; “More Nurses in Nursing Homes Would Mean Fewer Patients Headed to Hospitals” (March 10, 2011), http://www.medicareadvocacy.org/more-nurses-in-nursing-homes-will-mean-fewer-patients-headed-to-hospitals/; “Preventable Emergency Department Visits by Nursing Home Residents” (Aug. 19, 2010), http://www.medicareadvocacy.org/InfoByTopic/SkilledNursingFacility/10_08.19.PreventableEmergencyVisits.htm.

3. Any effort to avoid rehospitalization must recognize observation status and other long outpatient stays as types of hospitalizations.  Observation status refers to patients in acute care hospitals being called outpatients, even though, like inpatients, they receive nursing and medical care, diagnostic tests and procedures, therapy, prescription and over-the-counter medications, and food and the patients may remain in a hospital bed for multiple days.  The care provided to inpatients and observation status patients is indistinguishable.  Any effort to reduce hospital admissions must recognize observation status as a hospital admission by another name.  See additional information on observation status at http://www.medicareadvocacy.org/medicare-info/observation-status/

A Technical Expert Panel to consider a readmission/rehospitalization measure strongly supported counting observation time.  RTI wrote in an August 23, 2012 paper entitled “Key Issues for TEP Consideration,” “The TEP was definitive that the SNF HRRM should include observation stays.  RTI agrees that observation stays should be included in the measure.” 

Observation status should be counted because the issue, for purposes of readmission, is whether a SNF sent the resident to the hospital for care and treatment.  Whether the resident is called an inpatient or an outpatient (in observation status) is not within the control of the SNF; the decision about how to classify a patient in the hospital is made solely by the hospital.  However, what is within the control of the SNF is the decision to send the resident to the hospital in the first place.  If the SNF sends a resident to the hospital, its decision to hospitalize the patient is a rehospitalization decision.  Whether the hospital calls the patient an inpatient or an outpatient (observation status) is irrelevant and has no significance for purposes of the rehospitalization quality measure. 

Over the past few years, hospitals have increasingly categorized patients as outpatients in observation status, largely because of their concern about the Recovery Auditor (formerly known as Recovery Auditor Contractor (RAC) program).  Under the procedures, if a RAC reviewed a hospital’s decision to classify a patient as an inpatient and decided that the patient should have been classified as an outpatient, the hospital had to return the Medicare reimbursement it received and was left with virtually no reimbursement from the Medicare program for whatever medically necessary services it provided.  Avoiding RAC review, and the significant financial consequences of a RAC’s reversal of an inpatient decision, led hospitals to call increasing numbers of patients “outpatients” in observation status. 

While Quality Improvement Organizations replaced RACs as the initial reviewers of hospital admission decisions and CMS recently placed the QIO review process on hold, hospitals nevertheless remain concerned about classifying patients as inpatients.  The common use of observation status leads to highly inaccurate data on rehospitalization rates.

Researchers documented that hospitals’ use of outpatient observation status paralleled the decline in inpatient stays.  Reviewing 100% of Medicare claims data for 2007-2009, researchers found that the number of outpatient observation stays for Medicare beneficiaries increased over the three-year period, while inpatient admissions decreased, suggesting “a substitution of outpatient observation services for inpatient admissions.”  Zhanlian Feng, David B. Wright, and Vincent Mor, “Sharp Rise In Medicare Enrollees Being Held In Hospitals For Observation Raises Concerns About Causes And Consequences,” Health Affairs 31, No. 6 (2012).

Observation and other outpatient status time must be recognized as rehospitalization.

Proposed measures

We support use of claims-based measures, rather than measures based on self-reported minimum data set (MDS) information, which are too susceptible to gaming by providers.

We also support CMS’s determination not to limit the 30-day potentially preventable readmission measure to readmissions during a SNF stay and to count both within-stay hospital readmissions and post-stay hospital readmissions.  81 Fed. Reg., 24244-24245. 

However, we propose that the time period for rehospitalization should be 90 days, not 30 days.  Thirty days is too short a period for this measure.  A rapid rehospitalization may reflect poor care at the hospital or a premature discharge; rehospitalization later in a resident’s stay may reflect poor care provided by the nursing facility.  We note that other efforts underway to change health care delivery systems that also seek to reduce rehospitalization, such as bundling demonstrations, use a 90-day time period following hospitalization.

Finally, the Center proposes that CMS promulgate regulations prohibiting payment of a bonus under the Value-Based Purchasing Program to any nursing facility that, regardless of its performance under VBP,

  • Does not accurately report staffing data to CMS;
  • Does not have sufficient nursing staff to meet each resident’s needs.

SNF Quality Reporting Program

            Sociodemographic status

We strongly support CMS’s determination not to use sociodemographic status in quality measurement.  CMS write, “[W]e continue to have concerns about holding providers to different standards for the outcomes of their patients of diverse sociodemographic status because we do not want to mask potential disparities or minimize incentives to improve the outcomes of disadvantaged populations.”  81 Fed. Reg., 24257.  We support this statement and encourage CMS to hold firm on this issue.

We are concerned that risk adjustment for quality reporting and pay-for-performance programs based on SES/SDS factors will lead to several harmful unintended consequences for poor and minority residents.  First, risk adjustment has the potential to mask existing disparities in care that low-income patients receive, rather than expose and address these disparities.  Simply adjusting away these real differences only perpetuates the inequities.

Moreover, risk adjustment could create two divergent standards of care for SNFs based on the wealth or poverty of the populations they serve.  Adjusting scores for SNFs with significant proportions of poor and minority populations would in effect lower the bar for facilities that treat these populations.  This type of adjustment allows distinct and unequal standards for poor patients and wealthy patients.

Finally, the root of the disparities in care is not likely to be addressed if the differences are concealed through the automatic and inaccurate inflation of performance scores. 

Research documenting that poor and minority residents have better outcomes when they get care in better quality hospitals and SNFs illustrates flaws in using socioeconomic data to adjust Medicare ratings.  A study analyzing readmissions to hospitals from nursing homes found that hospital readmission rates within 30 days from nursing homes were lower when the quality of both the hospitals and nursing homes was better.  Kali S. Thomas, Momotazur Rahman, Vincent Mor, and Oma Intrator, “Influence of Hospital and Nursing Home Quality on Hospital Readmissions,” Am J Manag Care, 2014; 20(11):e523-e531 (published online Feb. 10, 2015), http://www.ajmc.com/publications/issue/2014/2014-vol20-n11/Influence-of-Hospital-and-Nursing-Home-Quality-on-Hospital-Readmissions.   The study used a “retrospective, statistical association-based research design” to analyze hospital and nursing home minimum data set (MDS) data for 2006-2008.  The study’s findings were based on a final sample of 1,382,477 individualized hospitalizations and discharges to 15,356 nursing homes from 3683 hospitals.

“Hospital quality was assessed using staffing levels [National Quality Forum measure #0204] and processes of care measures [one for each of three clinical areas, AMI, CHF, and pneumonia].”  Nursing home quality was measured by nurse staffing (RN, LPN, aides) hours per resident day and weighted deficiency citations, based on annual surveys. 

The researchers found that 22% of residents were rehospitalized within 30 days of discharge from the hospital.  “Approximately 5% of patients were discharged from higher-quality hospitals (those with AMI, CHR, and pneumonia scores greater than 90% and whose ratio of RNs to licensed nurses were greater than the mean) to higher-quality NHs (those with staffing ratios greater than the mean and weighted deficiency scores less than the mean).”  Approximately 59% of patients were discharged from lower quality hospitals to lower-quality nursing homes. 

Nursing home residents were more likely to be rehospitalized when their nursing homes

  • had lower nurse staffing levels.  Lower RN staffing levels were associated with an increase in rehospitalization of 0.19%.
  • had more weighted deficiencies.  A higher weighted deficiency score was associated with an increase in rehospitalization of 0.16%.
  • had low occupancy rates.  Low occupancy rates were associated with an increase in rehospitalization of 0.55%, “representing a 3% relative increase over the unadjusted mean likelihood of rehospitalization.”
  • “Patients who were discharged to freestanding, for-profit NHs with a higher proportion of Medicaid residents and a higher number of admissions per bed were associated with an increased likelihood of rehospitalization.”

The researchers found that hospital and nursing home quality accounted for 2.8% of the variation in rehospitalization rates and that many factors beyond providers’ control, such as “demographic characteristics, functional impairment, cognitive functioning, and even preferences [i.e., advance directives], affect rehospitalization.”  Nevertheless, they conclude, “Increased attention and efforts to boost the quality of lower-performing NHs may have the added benefit of reducing the rehospitalization rate.” 

            IMPACT Act

The Center supports the development of quality measures across post-acute settings that will make more meaningful comparisons of post-acute settings possible.  Nevertheless, we have concerns about the measures that CMS is developing.

            IMPACT Act Domains of Resource Use and Other Measures, MSPB-PAC SNF QRP

The Center is concerned about the measure Medicare spending per beneficiary post acute care (MSPB-PAC SNF), which appears to be limited to Medicare payments under both Parts A and B during an episode window.  The measure’s focus on Medicare is flawed.  Unless a comprehensive measure considers ALL sources of funding for post-SNF care, not just Medicare payments, SNFs will have an incentive to discontinue Medicare coverage for a beneficiary and shift ongoing costs to another payer, such as Medicaid.  We have seen cost-shifting like this before. 

When Congress enacted a prospective payment system for acute care hospitals, one explicit purpose was reducing hospital costs.  A considerable amount of research found, as expected, that hospital lengths of stay were reduced following the introduction of PPS.  There is certainly a benefit to that result, in and of itself, both for public payment systems and for beneficiaries.  But some less predictable and less beneficial results also occurred. 

Research on the treatment of beneficiaries with hip fractures found enormous changes in care settings and costs following the implementation of PPS.  One study found that before PPS, patients received rehabilitation in the hospital and generally went home, either directly from the hospital or following a short stay in a SNF.  After PPS, hospital lengths of stay declined from 22 days to 13 days and the percentage of residents discharged to SNFs increased from 38% to 60%.  The expectation was that patients could get the same rehabilitation services in SNFs that they had received in acute care hospitals, but at lower cost.  This did not prove true.  After PPS, the researchers found that, for various reasons, “rehabilitation therapy within the nursing homes was less effective than inpatient therapy before PPS.”  The outcomes for patients with hip fracture were worse following PPS.  Instead of getting therapy and returning home, patients were more likely to be in the nursing home a full year after their hip fracture; a 200% increase in the rate of nursing home residence was reported by the study after PPS was implemented.  John F. Fitzgerald, M.D., et al, “The Care of Elderly Patients with Hip Fracture,” New England Journal of Medicine 319(21):1392-1397 (Nov. 24, 1988).  The researchers called this finding “alarming” and their most important finding.  Services were not the same in the different settings.

Not only were care outcomes worse for beneficiaries with hip fractures following PPS, but expected cost savings also did not materialize as costs moved elsewhere.  After PPS, people with hip fractures spent less time in the hospital, but these patients became Medicare patients in SNFs and then, frequently, as the researchers found, long-term residents of nursing homes.  Medicare payments to SNFs increased in the years following implementation of PPS for hospitals.  And patients who would have gone home from the hospital now found themselves living in nursing facilities on a long-term basis, generally, as Medicaid beneficiaries.  Savings in Medicare acute care hospital costs were accompanied by increases in Medicare and Medicaid post-acute costs.   Costs shifted from one setting to another, with worse care outcomes for beneficiaries.  Lessons learned from this experience are that lower-cost settings do not necessarily provide comparable services and that new health care costs may emerge in other settings.

By counting only Medicare payments following a SNF stay, the MSPB-PAC SNF measure may not actually measure the real costs of ongoing care after a SNF stay; it may simply lead to cost-shifting to Medicaid and other payers.

            Discharge to Community-Post Acute Care (PAC)

This measure reflects an important concern of Medicare beneficiaries – returning home following care.

The Center has two concerns.  First, we fully support CMS’s recognition that the measure is not limited to beneficiaries who are returning to their prior level of functioning and independence.  As CMS recognizes, “Returning to the community is also an important outcome for many residents who are not expected to make functional improvement during their SNF stay, and for residents who may be expected to decline functionally due to their medical condition.”  81 Fed. Reg., 24262.  Medicare coverage for maintenance nursing and therapy, as confirmed by Jimmo v. Burwell, Civ. No. 5:11-CV-17 (D. VT, Jan. 18, 2011), must be ensured and reflected by the discharge measure.

Second, we believe that discharge to a nursing facility should not be treated like a discharge to the community, even when a nursing facility was the resident’s prior (pre-hospital, pre-SNF) residence.  Counting a return to a nursing facility just like a return to the community would give SNFs an unjustified boost in their ratings and provide an incentive not to do the hard work that actual, meaningful discharge planning requires.

            Potentially Preventable 30-Day Post-Discharge Readmission Measure

For the reasons discussed above, we are concerned about rehospitalization measures.  Our concerns are as applicable for reporting purposes as for payment.

            Drug Regiment Review Conducted with Follow-Up for Identified Issues

The Center recognizes the critical importance of medication reconciliation and brings to CMS’s attention a study finding that registered nurses (RNs) are more likely to identify medication discrepancies in nursing facilities than licensed practical nurses (LPNs). 

Reporting that “70% of nursing home residents have at least one discrepancy in their medication

order” when they are admitted from another health care setting, a study evaluates how RNs and LPNs detect discrepancies in medication orders. Amy Vogelsmeier, Allison Anbari, Larry Ganong, Ruth A. Anderson, Lynda Oderda, Amany Farag, and Richard Madsen, “Detecting Medication Order Discrepancies in Nursing Homes: How RNs and LPNs Differ,” Journal of Nursing Regulation, Vol. 6, Issue 3, page 48 (Oct. 2015).

The study found that RNs identified more discrepancies, especially with high-risk medications.

Identification of Detection of Medication Discrepancies, RNs and LPNs

Article 53.

The researchers describe as “perhaps one of their most important findings” that

RNs more often identified discrepancies in medication orders involving high-risk medications, suggesting that RNs assess orders for discrepancies based on the potential risk to resident safety.  In contrast, LPN responses were similar regardless of the medication risk level, suggesting that LPNs are following rote instructions to complete the task for medication reconciliation rather than engaging in cognitive behavior regarding risk.

Id. 54. They conclude, “RNs are more likely than LPNs to identify high-risk medications as discrepancies, suggesting RNs may have a greater clinical focus on assessment and problem identification, including risk to resident safety.” Id.  The researchers express concern about nursing facilities’ using RNs interchangeably with LPNs, especially “because of the rising acuity of resident care.” Id.

The Center encourages CMS, in the Requirements of Participation for skilled nursing facilities and nursing facilities, to require that facilities employ RNs 24 hours per day.

This measure, if properly implemented, will be a proxy for nurse staffing.

Thank you for the opportunity to submit comments.

Respectfully submitted,

Toby S. Edelman
Senior Policy Attorney